Colorectal Cancer
Conditions
Keywords
adenocarcinoma of the rectum, stage IIA rectal cancer, stage IIB rectal cancer, stage IIC rectal cancer, stage IIIA rectal cancer, stage IIIB rectal cancer, stage IIIC rectal cancer
Brief summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying the side effects and how well giving oxaliplatin, capecitabine, and cetuximab together with radiation therapy followed by surgery works in treating patients with stage II or stage III rectal cancer.
Detailed description
OBJECTIVES: * To assess the pathologic complete response rate for the combination of oxaliplatin, capecitabine, and cetuximab alone and concurrently with external beam radiotherapy for patients with adenocarcinoma of the rectum, stages II and III with wild-type K-ras. * To estimate the 3-year disease-free survival probability in this patient population when treated with this regimen. * To assess the frequency and severity of toxicities associated with this regimen in these patients. * To explore, preliminarily, the association between expression levels of genes involved in the DNA repair, EGFR (epidermal growth factor receptor), angiogenesis, and 5-FU pathway (i.e., k-ras, TS \[Thymidylate Synthase\], ERCC-1 \[excision repair cross complementing-1), TP \[Thymidine phosphorylase\], DPD \[Dihydropyrimidine dehydrogenase\], EGFR, VEGF \[vascular endothelial growth factor\], and IL-8 \[interleukin-8\]) and pathologic complete response. (Due to advances in methodology, the translational medicine objectives are being reconsidered. Therefore, results for this objective are not reported) * To explore, preliminarily, the intratumoral gene expression levels of these genes after completion of study treatment.(Due to advances in methodology, the translational medicine objectives are being reconsidered. Therefore, results for this objective are not reported) * To obtain, preliminarily, data on genomic polymorphisms of these genes for correlation with clinical outcome and toxicity. (Due to advances in methodology, the translational medicine objectives are being reconsidered. Therefore, results for this objective are not reported) OUTLINE: This is a multicenter study. * Neoadjuvant therapy (course 1): Patients receive oxaliplatin IV over 2 hours once a week for 5 weeks, oral capecitabine twice daily 5 days a week for 5 weeks, and cetuximab IV over 1-2 hours once a week for 5 weeks. * Neoadjuvant therapy with concurrent radiotherapy (course 2): Beginning two weeks later, patients receive oxaliplatin IV over 2 hours once a week in weeks 1, 2, 4, and 5. Patients also receive capecitabine and cetuximab as in course 1. Patients also undergo external beam radiotherapy 5 days a week for 5 weeks beginning in week 1. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo surgery 3-8 weeks after completion of chemoradiotherapy. Blood samples are collected for germline polymorphism testing and tissue samples are collected and assessed for gene expression analysis. After completion of study treatment, patients are followed every 6 months for 4 years.
Interventions
BIOLOGICALcetuximab
Chemotherapy cycle 1: Cetuximab, 400 mg/m\^2, IV, Day 1; Cetuximab, 250 mg/m\^2, IV, Days 8,15,22,29 Chemotherapy+ Radiation Cycle 2: Cetuximab, 250 mg/m\^2, IV, Days 50,57,64,71,78
DRUGcapecitabine
Chemotherapy Cycle 1: Capecitabine, 1650 mg/m\^2/day, PO, Monday-Friday (Day 1-35) Chemotherapy+ Radiation Cycle 2: Capecitabine, 1650 mg/m\^1, PO, Monday-Friday (Day 50-84)
DRUGoxaliplatin
Chemotherapy Cycle 1: Oxaliplatin, 50 mg/m\^2, IV, Days 1,8,15,22,29 Chemotherapy+ Radiation Cycle 2: Oxaliplatin, 50 mg/m\^2, IV, Days 50,57,71,78
PROCEDUREtherapeutic surgical procedure
Surgical resection
RADIATIONradiation therapy
IMRT (intensity-modulated radiation therapy)
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Biopsy-proven primary adenocarcinoma of the rectum * Stage II or III disease * The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 cm of the anal verge by proctoscopic examination * No recurrent disease * Must have wild-type k-ras status * Measurable and/or nonmeasurable disease PATIENT CHARACTERISTICS: * Zubrod performance status 0-2 * Leukocyte count ≥ 3,000/mcL * Granulocyte count ≥ 1,500/mcL * Platelet count ≥ 100,000/mcL * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * SGOT (serum glutamate oxaloacetate transaminase) or SGPT (serum glutamate pyruvate transaminase)≤ 2.5 times ULN * Creatinine clearance \> 50 mL/min * No prior severe reaction to a monoclonal antibody * Willing to have specimens submitted * No peripheral neuropathy ≥ grade 2 * No known existing uncontrolled coagulopathy * No evidence of current high-grade obstruction * At least 2 weeks since prior diverting procedure * No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol treatment * No prior unanticipated severe reaction to fluoropyrimidine therapy or known sensitivity to fluorouracil or known DPD deficiency * No active inflammatory bowel disease, malabsorption syndrome, or inability to swallow that would impair the ingestion or absorption of capecitabine * No uncontrolled intercurrent illness * No ongoing or active infection * No symptomatic congestive heart failure or unstable angina pectoris * No cardiac arrhythmia or myocardial infarction within the past 12 months * Not pregnant or nursing * Fertile patients must use effective contraception * No prior malignancy allowed except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other cancer from which the patient has been disease-free for 5 years PRIOR CONCURRENT THERAPY: * Recovered from any recent major surgeries (e.g., coronary artery bypass graft, transurethral resection of prostate, or abdominal surgery) * No prior chemotherapy, radiotherapy, or targeted therapy for this tumor * More than 4 weeks since prior investigational agents * No concurrent anti-retroviral therapy for HIV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Complete Response Rate | 15-20 weeks from registration | Pathologic response is evaluated after the patient has had surgery, and is based on local pathology review of the resected surgical specimen, according to the following: a) Pathologic complete response (pCR): on review of the resected rectal specimen and accompanying lymph nodes, no cancer is recognized by the pathologist; b) Microscopic cancer: gross tumor is not seen by the pathologist but tumor remains in the microscopic analysis of any part of the entire specimen; c) no response: gross cancer is found on pathologic examination of the resected rectal cancer and draining lymph nodes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year Disease-free Survival | 3 years | From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Up to 4 years | Only adverse events that are possibly, probably or definitely related to study regimen are reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chemo + Chemo and Radiation + Surgery Chemotherapy Cycle 1 (1 cycle is 35 days):
* Oxaliplatin, 50 mg/m\^2, IV, Days 1,8,15,22,29
* Cetuximab, 400 mg/m\^2, IV, Day 1
* Cetuximab, 250 mg/m\^2, IV, Days 8,15,22,29
* Capecitabine, 1650 mg/m\^2/day, PO, Monday-Friday (Day 1-35)
Chemotherapy+ Radiation Cycle 2:
* Oxaliplatin, 50 mg/m\^2, IV, Days 50,57,71,78
* Cetuximab, 250 mg/m\^2, IV, Days 50,57,64,71,78
* Capecitabine, 1650 mg/m\^1, PO, Monday-Friday (Day 50-84)
* Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
Therapeutic Surgical procedure: Resection | 74 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Death | 1 |
| Overall Study | Did not begin protocol therapy | 4 |
| Overall Study | Ineligible | 5 |
| Overall Study | Not Protocol Specified | 1 |
| Overall Study | Progression/Relapse | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Chemo + Chemo and Radiation + Surgery |
|---|---|
| Age, Continuous | 56.4 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 67 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 63 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 73 / 74 | 66 / 68 | 51 / 63 |
| serious Total, serious adverse events | 1 / 74 | 0 / 68 | 0 / 63 |
Outcome results
Primary
Pathologic Complete Response Rate
Pathologic response is evaluated after the patient has had surgery, and is based on local pathology review of the resected surgical specimen, according to the following: a) Pathologic complete response (pCR): on review of the resected rectal specimen and accompanying lymph nodes, no cancer is recognized by the pathologist; b) Microscopic cancer: gross tumor is not seen by the pathologist but tumor remains in the microscopic analysis of any part of the entire specimen; c) no response: gross cancer is found on pathologic examination of the resected rectal cancer and draining lymph nodes.
Time frame: 15-20 weeks from registration
Population: Eligible and analyzable patients with available data. It was assumed that a pathologic complete response was not achieved for patients who do not receive surgery or for whom a surgical specimen is lacking. These patients were included in the denominator.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemo + Chemo and Radiation + Surgery | Pathologic Complete Response Rate | 25 percentage of participants |
p-value: 0.18Exact binomal test
Secondary
3-year Disease-free Survival
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
Time frame: 3 years
Population: Eligible and analyzable patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemo + Chemo and Radiation + Surgery | 3-year Disease-free Survival | 68 percentage of participants |
Secondary
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.
Only adverse events that are possibly, probably or definitely related to study regimen are reported.
Time frame: Up to 4 years
Population: Eligible patients who received any treatment and were assessed for adverse events are included in this summary.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Flushing | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | AST, SGOT | 15 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Acidosis (metabolic or respiratory) | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Adult respiratory distress syndrome (ARDS) | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Albumin, serum-low (hypoalbuminemia) | 11 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Alkaline phosphatase | 4 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Allergic reaction/hypersensitivity | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Allergic rhinitis | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Amylase | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Anorexia | 20 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Bicarbonate, serum-low | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Bilirubin (hyperbilirubinemia) | 5 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Blood/Bone Marrow-Other | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Bone: spine-scoliosis | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Bruising (in absence of Gr 3-4 thrombocytopenia) | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Burn | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Calcium, serum-low (hypocalcemia) | 8 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Coagulation-Other | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Colitis | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Confusion | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Constipation | 34 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Constitutional Symptoms-Other | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Cough | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Creatinine | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Cystitis | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Cytokine release syndrome/acute infusion reaction | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dehydration | 8 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dermatology/Skin-Other | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Diarrhea | 34 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Distention/bloating, abdominal | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dizziness | 10 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dry mouth/salivary gland (xerostomia) | 7 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dry skin | 20 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dysphagia (difficulty swallowing) | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dyspnea (shortness of breath) | 5 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Edema: limb | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Enteritis (inflammation of the small bowel) | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Extrapyramidal/involuntary movement/restlessness | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Fatigue (asthenia, lethargy, malaise) | 48 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Fever in absence of neutropenia, ANC lt1.0x10e9/L | 4 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Flatulence | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Flu-like syndrome | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | ALT, SGPT (serum glutamic pyruvic transaminase) | 15 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Gastritis (including bile reflux gastritis) | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Gastrointestinal-Other | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Glucose, serum-high (hyperglycemia) | 13 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hair loss/Alopecia (scalp or body) | 4 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Heartburn/dyspepsia | 13 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hemoglobin | 13 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hemolysis | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hemorrhage, GI - Rectum | 9 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hemorrhage/Bleeding-Other | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hemorrhage/bleeding w/surgery, intra- or post-op | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hemorrhoids | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hepatobiliary/Pancreas-Other | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hiccoughs (hiccups, singultus) | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hot flashes/flushes | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hyperpigmentation | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hypertension | 3 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hypotension | 4 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | INR (of prothrombin time) | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Ileus, GI (functional obstruction of bowel) | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Incontinence, anal | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Incontinence, urinary | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Inf w/normal ANC or Gr 1-2 neutrophils - UTI | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Inf w/normal ANC or Gr 1-2 neutrophils - Vagina | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Inf w/normal ANC or Gr 1-2 neutrophils - Wound | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Infection with unknown ANC - Abdomen NOS | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Infection with unknown ANC - Anal/perianal | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Infection with unknown ANC - Sinus | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Infection with unknown ANC - Urinary tract NOS | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Infection-Other | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Injection site reaction/extravasation changes | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Insomnia | 4 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Irregular menses (change from baseline) | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Leak (including anastomotic), GU - Stoma | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Leukocytes (total WBC) | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Lipase | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Lymphatics-Other | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Lymphopenia | 4 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Magnesium, serum-high (hypermagnesemia) | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Magnesium, serum-low (hypomagnesemia) | 3 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Metabolic/Laboratory-Other | 3 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mood alteration - agitation | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mood alteration - anxiety | 6 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mood alteration - depression | 4 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mucositis/stomatitis (clinical exam) - Anus | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mucositis/stomatitis (clinical exam) - Oral cavity | 14 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mucositis/stomatitis (functional/symp) - Anus | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mucositis/stomatitis (functional/symp) - Oral cav | 9 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mucositis/stomatitis (functional/symp) - Rectum | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Muscle weakness, not d/t neuropathy - Extrem-lower | 3 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Muscle weakness, not d/t neuropathy - Extrem-upper | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Muscle weakness, not d/t neuropathy - body/general | 3 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Musculoskeletal/Soft Tissue-Other | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Nail changes | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Nasal cavity/paranasal sinus reactions | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Nausea | 37 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Neurology-Other | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Neuropathy: motor | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Neuropathy: sensory | 38 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Neutrophils/granulocytes (ANC/AGC) | 4 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Obstruction, GI - Rectum | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Obstruction, GI - Small bowel NOS | 3 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Ocular/Visual-Other | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | PTT (Partial thromboplastin time) | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Abdomen NOS | 8 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Anus | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Back | 4 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Bone | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Chest/thorax NOS | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Esophagus | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Extremity-limb | 3 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Face | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Head/headache | 10 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Joint | 5 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Kidney | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Muscle | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Oral cavity | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Pelvis | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Perineum | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Rectum | 5 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Urethra | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Vagina | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain-Other | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Phlebitis (including superficial thrombosis) | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Phosphate, serum-low (hypophosphatemia) | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Photosensitivity | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Platelets | 9 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pleural effusion (non-malignant) | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Potassium, serum-high (hyperkalemia) | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Potassium, serum-low (hypokalemia) | 14 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Proctitis | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pruritus/itching | 15 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pulmonary hypertension | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pulmonary/Upper Respiratory-Other | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rash/desquamation | 7 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rash: acne/acneiform | 64 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rash: dermatitis associated w/Chemoradiation | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rash: dermatitis associated w/radiation | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rash: erythema multiforme | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rash: hand-foot skin reaction | 12 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Renal failure | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Renal/Genitourinary-Other | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rigors/chills | 3 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | SVT and nodal arrhythmia - Atrial fibrillation | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | SVT and nodal arrhythmia - Atrial tachycardia/PAT | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | SVT and nodal arrhythmia - Sinus tachycardia | 3 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Sexual/Reproductive Function-Other | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Sodium, serum-high (hypernatremia) | 2 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Sodium, serum-low (hyponatremia) | 7 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Somnolence/depressed level of consciousness | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Sweating (diaphoresis) | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Syncope (fainting) | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Taste alteration (dysgeusia) | 3 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Thrombosis/embolism (vascular access-related) | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Thrombosis/thrombus/embolism | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Tinnitus | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Tremor | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Urinary frequency/urgency | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Urinary retention (including neurogenic bladder) | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Vascular-Other | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Ventricular arrhythmia - Ventricular tachycardia | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Vision-blurred vision | 1 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Vomiting | 13 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Weight gain | 0 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Weight loss | 11 Participants |
| Chemo + Chemo and Radiation + Surgery | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Wound complication, non-infectious | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Sodium, serum-high (hypernatremia) | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | ALT, SGPT (serum glutamic pyruvic transaminase) | 11 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Incontinence, urinary | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Extremity-limb | 4 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | AST, SGOT | 12 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rash: erythema multiforme | 2 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mood alteration - depression | 2 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Acidosis (metabolic or respiratory) | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hypertension | 2 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Infection-Other | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Adult respiratory distress syndrome (ARDS) | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mucositis/stomatitis (clinical exam) - Anus | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Face | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Albumin, serum-low (hypoalbuminemia) | 10 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pruritus/itching | 5 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Tinnitus | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Alkaline phosphatase | 5 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mucositis/stomatitis (clinical exam) - Oral cavity | 4 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Wound complication, non-infectious | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Allergic reaction/hypersensitivity | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Injection site reaction/extravasation changes | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Head/headache | 3 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Allergic rhinitis | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rash: hand-foot skin reaction | 12 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mucositis/stomatitis (functional/symp) - Anus | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Amylase | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Inf w/normal ANC or Gr 1-2 neutrophils - UTI | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Sodium, serum-low (hyponatremia) | 6 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Anorexia | 18 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rash/desquamation | 5 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Joint | 2 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Bicarbonate, serum-low | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mucositis/stomatitis (functional/symp) - Oral cav | 2 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Insomnia | 6 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Bilirubin (hyperbilirubinemia) | 3 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Urinary frequency/urgency | 4 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mucositis/stomatitis (functional/symp) - Rectum | 4 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Blood/Bone Marrow-Other | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | INR (of prothrombin time) | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Kidney | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Bone: spine-scoliosis | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Renal failure | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Muscle weakness, not d/t neuropathy - Extrem-lower | 2 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Bruising (in absence of Gr 3-4 thrombocytopenia) | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hyperpigmentation | 5 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Ventricular arrhythmia - Ventricular tachycardia | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Burn | 2 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Irregular menses (change from baseline) | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Muscle | 2 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Calcium, serum-low (hypocalcemia) | 13 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Muscle weakness, not d/t neuropathy - Extrem-upper | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Inf w/normal ANC or Gr 1-2 neutrophils - Vagina | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Coagulation-Other | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Proctitis | 5 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Somnolence/depressed level of consciousness | 2 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Colitis | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Muscle weakness, not d/t neuropathy - body/general | 4 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Oral cavity | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Confusion | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Leak (including anastomotic), GU - Stoma | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Renal/Genitourinary-Other | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Constipation | 24 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Musculoskeletal/Soft Tissue-Other | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Ileus, GI (functional obstruction of bowel) | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Constitutional Symptoms-Other | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rash: acne/acneiform | 42 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Pelvis | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Cough | 6 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Nail changes | 3 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Leukocytes (total WBC) | 6 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Creatinine | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Weight gain | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Nasal cavity/paranasal sinus reactions | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Cystitis | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Inf w/normal ANC or Gr 1-2 neutrophils - Wound | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Perineum | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Cytokine release syndrome/acute infusion reaction | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rigors/chills | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Nausea | 25 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dehydration | 11 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hot flashes/flushes | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Sweating (diaphoresis) | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dermatology/Skin-Other | 2 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Lipase | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Rectum | 20 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Diarrhea | 48 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Neurology-Other | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pulmonary hypertension | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Distention/bloating, abdominal | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Urinary retention (including neurogenic bladder) | 2 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Neuropathy: motor | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dizziness | 7 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Infection with unknown ANC - Abdomen NOS | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Urethra | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dry mouth/salivary gland (xerostomia) | 6 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | SVT and nodal arrhythmia - Atrial fibrillation | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Neuropathy: sensory | 34 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dry skin | 16 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Lymphatics-Other | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Weight loss | 15 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dysphagia (difficulty swallowing) | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hypotension | 2 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Vagina | 2 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dyspnea (shortness of breath) | 4 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Neutrophils/granulocytes (ANC/AGC) | 9 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rash: dermatitis associated w/Chemoradiation | 7 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Edema: limb | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Lymphopenia | 13 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Syncope (fainting) | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Enteritis (inflammation of the small bowel) | 2 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Obstruction, GI - Rectum | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain-Other | 3 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Extrapyramidal/involuntary movement/restlessness | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Incontinence, anal | 4 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | SVT and nodal arrhythmia - Atrial tachycardia/PAT | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Fatigue (asthenia, lethargy, malaise) | 41 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Obstruction, GI - Small bowel NOS | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Infection with unknown ANC - Anal/perianal | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Fever in absence of neutropenia, ANC lt1.0x10e9/L | 4 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Magnesium, serum-high (hypermagnesemia) | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Phlebitis (including superficial thrombosis) | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Flatulence | 5 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Ocular/Visual-Other | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Potassium, serum-low (hypokalemia) | 14 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Flu-like syndrome | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Tremor | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Vision-blurred vision | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Flushing | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | PTT (Partial thromboplastin time) | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Phosphate, serum-low (hypophosphatemia) | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Gastritis (including bile reflux gastritis) | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Magnesium, serum-low (hypomagnesemia) | 4 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | SVT and nodal arrhythmia - Sinus tachycardia | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Gastrointestinal-Other | 6 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Abdomen NOS | 19 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Taste alteration (dysgeusia) | 4 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Glucose, serum-high (hyperglycemia) | 12 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Vomiting | 5 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Photosensitivity | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hair loss/Alopecia (scalp or body) | 3 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rash: dermatitis associated w/radiation | 4 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Anus | 5 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Heartburn/dyspepsia | 4 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Metabolic/Laboratory-Other | 4 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Vascular-Other | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hemoglobin | 19 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Back | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Platelets | 13 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hemolysis | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Infection with unknown ANC - Sinus | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Sexual/Reproductive Function-Other | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hemorrhage, GI - Rectum | 6 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Bone | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Thrombosis/thrombus/embolism | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hemorrhage/Bleeding-Other | 2 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mood alteration - agitation | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pleural effusion (non-malignant) | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hemorrhage/bleeding w/surgery, intra- or post-op | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Chest/thorax NOS | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pulmonary/Upper Respiratory-Other | 2 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hemorrhoids | 5 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Infection with unknown ANC - Urinary tract NOS | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Thrombosis/embolism (vascular access-related) | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hepatobiliary/Pancreas-Other | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Esophagus | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Potassium, serum-high (hyperkalemia) | 0 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hiccoughs (hiccups, singultus) | 1 Participants |
| Chemotherapy + Radiation | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mood alteration - anxiety | 3 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hiccoughs (hiccups, singultus) | 2 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hot flashes/flushes | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Thrombosis/embolism (vascular access-related) | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hyperpigmentation | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hypertension | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Potassium, serum-low (hypokalemia) | 4 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hypotension | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Weight loss | 12 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | INR (of prothrombin time) | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Ileus, GI (functional obstruction of bowel) | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Proctitis | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Incontinence, anal | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Incontinence, urinary | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Inf w/normal ANC or Gr 1-2 neutrophils - UTI | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pruritus/itching | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Inf w/normal ANC or Gr 1-2 neutrophils - Vagina | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Thrombosis/thrombus/embolism | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Inf w/normal ANC or Gr 1-2 neutrophils - Wound | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Infection with unknown ANC - Abdomen NOS | 2 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pulmonary hypertension | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Infection with unknown ANC - Anal/perianal | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Infection with unknown ANC - Sinus | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Infection with unknown ANC - Urinary tract NOS | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pulmonary/Upper Respiratory-Other | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Infection-Other | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Injection site reaction/extravasation changes | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Insomnia | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rash/desquamation | 3 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Irregular menses (change from baseline) | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Tinnitus | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Leak (including anastomotic), GU - Stoma | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Leukocytes (total WBC) | 3 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rash: acne/acneiform | 9 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Lipase | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Vomiting | 4 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Lymphatics-Other | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Lymphopenia | 9 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rash: dermatitis associated w/Chemoradiation | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Magnesium, serum-high (hypermagnesemia) | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Magnesium, serum-low (hypomagnesemia) | 2 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Metabolic/Laboratory-Other | 2 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rash: dermatitis associated w/radiation | 2 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mood alteration - agitation | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Tremor | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mood alteration - anxiety | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mood alteration - depression | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rash: erythema multiforme | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mucositis/stomatitis (clinical exam) - Anus | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Wound complication, non-infectious | 2 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mucositis/stomatitis (clinical exam) - Oral cavity | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mucositis/stomatitis (functional/symp) - Anus | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rash: hand-foot skin reaction | 4 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mucositis/stomatitis (functional/symp) - Oral cav | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Mucositis/stomatitis (functional/symp) - Rectum | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Muscle weakness, not d/t neuropathy - Extrem-lower | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Renal failure | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Muscle weakness, not d/t neuropathy - Extrem-upper | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Urinary frequency/urgency | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Muscle weakness, not d/t neuropathy - body/general | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Musculoskeletal/Soft Tissue-Other | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Renal/Genitourinary-Other | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Nail changes | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Nasal cavity/paranasal sinus reactions | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Nausea | 7 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Rigors/chills | 2 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Neurology-Other | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Neuropathy: motor | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Neuropathy: sensory | 17 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | SVT and nodal arrhythmia - Atrial fibrillation | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Neutrophils/granulocytes (ANC/AGC) | 2 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Urinary retention (including neurogenic bladder) | 6 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Obstruction, GI - Rectum | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Obstruction, GI - Small bowel NOS | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | SVT and nodal arrhythmia - Atrial tachycardia/PAT | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Ocular/Visual-Other | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Weight gain | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | PTT (Partial thromboplastin time) | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Abdomen NOS | 7 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | SVT and nodal arrhythmia - Sinus tachycardia | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Anus | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Back | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Bone | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Sexual/Reproductive Function-Other | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Chest/thorax NOS | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Vascular-Other | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Esophagus | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | ALT, SGPT (serum glutamic pyruvic transaminase) | 3 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | AST, SGOT | 2 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Extremity-limb | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Acidosis (metabolic or respiratory) | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Sodium, serum-high (hypernatremia) | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Adult respiratory distress syndrome (ARDS) | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Albumin, serum-low (hypoalbuminemia) | 7 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Face | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Alkaline phosphatase | 3 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Allergic reaction/hypersensitivity | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Allergic rhinitis | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Head/headache | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Amylase | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Anorexia | 9 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Bicarbonate, serum-low | 2 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Joint | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Bilirubin (hyperbilirubinemia) | 2 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Sodium, serum-low (hyponatremia) | 6 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Blood/Bone Marrow-Other | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Bone: spine-scoliosis | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Kidney | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Bruising (in absence of Gr 3-4 thrombocytopenia) | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Burn | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Calcium, serum-low (hypocalcemia) | 9 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Muscle | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Coagulation-Other | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Colitis | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Confusion | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Oral cavity | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Constipation | 5 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Somnolence/depressed level of consciousness | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Constitutional Symptoms-Other | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Cough | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Pelvis | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Creatinine | 4 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Ventricular arrhythmia - Ventricular tachycardia | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Cystitis | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Cytokine release syndrome/acute infusion reaction | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Perineum | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dehydration | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dermatology/Skin-Other | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Diarrhea | 10 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Rectum | 17 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Distention/bloating, abdominal | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Sweating (diaphoresis) | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dizziness | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dry mouth/salivary gland (xerostomia) | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Urethra | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dry skin | 2 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dysphagia (difficulty swallowing) | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Dyspnea (shortness of breath) | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain - Vagina | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Edema: limb | 2 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Enteritis (inflammation of the small bowel) | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Extrapyramidal/involuntary movement/restlessness | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pain-Other | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Fatigue (asthenia, lethargy, malaise) | 22 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Syncope (fainting) | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Fever in absence of neutropenia, ANC lt1.0x10e9/L | 2 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Flatulence | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Phlebitis (including superficial thrombosis) | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Flu-like syndrome | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Flushing | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Gastritis (including bile reflux gastritis) | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Phosphate, serum-low (hypophosphatemia) | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Gastrointestinal-Other | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Glucose, serum-high (hyperglycemia) | 6 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hair loss/Alopecia (scalp or body) | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Photosensitivity | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Heartburn/dyspepsia | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Taste alteration (dysgeusia) | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hemoglobin | 21 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hemolysis | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Platelets | 6 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hemorrhage, GI - Rectum | 3 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Vision-blurred vision | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hemorrhage/Bleeding-Other | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hemorrhage/bleeding w/surgery, intra- or post-op | 2 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Pleural effusion (non-malignant) | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hemorrhoids | 1 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Hepatobiliary/Pancreas-Other | 0 Participants |
| Tumor Resection | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen. | Potassium, serum-high (hyperkalemia) | 1 Participants |