Recurrent Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
Conditions
Keywords
Non-small cell, Lung Cancer, Chemoradiation
Brief summary
This phase II trial studies how well giving a hypofractionated boost to the primary tumor before standard chemotherapy and radiation therapy works in treating patients with stage II or III non-small cell lung cancer that cannot be removed by surgery. Advances in radiation oncology have allowed better radiation targeting which may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells. Giving more precise and targeted radiation before standard chemotherapy and radiation therapy may kill more tumor cells and prevent the cancer from coming back in the location in which it started.
Detailed description
PRIMARY OBJECTIVES: I. To estimate the primary tumor control rate at 12 months. SECONDARY OBJECTIVES: I. To further establish safety and tolerability of this regimen. II. To estimate the rates of regional, distant control as well as progression-free survival and overall survival. III. To evaluate the objective response rate (ORR) to this regimen. IV. To evaluate the response of tumors to stereotactic (high-dose) radiation using magnetic resonance tumor perfusion imaging modalities (magnetic resonance \[MR\]-dynamic contrast-enhanced \[DCE\]/perfusion weighted imaging \[PWI\], MR-diffusion, blood oxygenation level dependent \[BOLD\] sequences). OUTLINE: Patients will receive a hypofractionated boost to the primary tumor over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin intravenously (IV) on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. If carboplatin and paclitaxel is administered concurrently with radiotherapy, 2 cycles of carboplatin (AUC=6 mg/min/mL IV on day 1, 22) and paclitaxel (200 mg/m2 IV on day 1, 22) consolidation chemotherapy are required, to be administered starting 4-6 weeks after concurrent chemoradiation has ended. Each cycle is 21 days long. If cisplatin and etoposide is administered concurrently with radiotherapy, consolidation chemotherapy is not allowed. Patients also undergo standard conformal radiation therapy once daily (QD) 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Interventions
RADIATIONhypofractionated radiation therapy
Radiation boost in week 1 (days 1-5)
DRUGcisplatin
Given IV
DRUGetoposide
Given IV
RADIATION3-dimensional conformal radiation therapy
Undergo 3-dimensional conformal radiation therapy
OTHERlaboratory biomarker analysis
Correlative studies
Sponsors
Ohio State University Comprehensive Cancer Center
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
* All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) =\< grade 1 (except alopecia) at the time of enrollment * Adequate baseline organ function obtained within 30 days of study registration * Absolute neutrophil count \>= 1.5 x 10\^9/L * Hemoglobin \>= 9 g/dL * Platelets \>= 100 x 10\^9/L * Total bilirubin =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN * Creatinine =\< 1.5 ULN AND * Calculated creatinine \>= 50 mL/min (calculated by the Cockcroft-Gault formula) or * 24-hour urine creatinine clearance \>= 50 mL/min * Non-small cell lung cancer (NSCLC), histologically and/or cytologically proven * Clinical American Joint Committee on Cancer (AJCC) stage (7th edition) IIA-IIIB NSCLC (T1-4N1-3M0) * Patients must be considered unresectable or medically-inoperable * Patients must have primary tumor =\< 6 cm as defined by CT largest axial dimension * Within 60 days of registration: patients must have fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)-CT scan (or CT chest/abdomen/pelvis with IV contrast), and magnetic resonance imaging (MRI) brain with IV contrast (or CT scan of the brain with contrast); a non-contrast MRI scans of the chest/abdomen/pelvis or brain are permitted for workup if patient has allergy to CT contrast or renal insufficiency * Within 30 days of registration: patients must have vital signs, history/physical examination, laboratory studies (complete blood count panel \[CBCP\] with differential, chemistries including liver function tests, creatinine clearance \[CrCl\] assessment, pregnancy test if needed within 14 days of registration) * If a pleural effusion is present and visible on both CT scan AND chest x-ray, the investigator should exclude malignant disease by pleurocentesis to confirm cytologically-negative pleural fluid; if fluid is exudative or cytologically positive for tumor cells, patient is excluded * Patients with effusions that are minimal (i.e. not visible on chest x-ray) and that are too small to safely tap are eligible. * Life expectancy of at least 12 weeks in the opinion of investigator * Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 30 days of registration * Patients must have measurable primary tumor (undetectable NSCLC primary tumor is ineligible) * Patients must be a minimum of 3 weeks from thoracotomy (if performed) and well-healed before starting treatment * Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed * Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of registration; urine human gonadotropin (HCG) is an acceptable pregnancy assessment * Nursing women may participate only if nursing is discontinued * Women/men of reproductive potential must be counseled on contraception/abstinence while receiving the study treatment
Exclusion criteria
* Patients with contralateral hilar involvement (greater than 1.5 cm on short axis or positive on PET scan, or biopsy-proven) * Documented or pathologically-proven metastatic disease * Presence of nodules considered neoplastic in the same lobe or other ipsilateral lobe as the primary tumor (stage T3-4), unless the nodule can be encompassed in the stereotactic boost (gross tumor volume \[GTV\]boost) without exceeding a total GTVboost size of 6 cm as defined by CT largest axial dimension * Presence of nodules considered neoplastic in contralateral lobes (M1a) * Patients with history of pneumonectomy * Prior cytotoxic chemotherapy or molecularly-targeted agents (e.g. erlotinib, crizotinib), unless \> 2 years prior * Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix; patients with a previous malignancy without evidence of disease for \>= 3 years will be allowed to enter the trial * History of active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis * History of previous radiation therapy which would result in overlapping radiation fields * Uncontrolled neuropathy grade 2 or greater, regardless of cause * Subjects who are breast-feeding and plan to continue breast-feeding during therapy, or have a positive pregnancy test will be excluded from the study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to Gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds) \[first 10 patients\] * Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator; this could include severe, active co-morbidities such as: * Unstable angina and/or congestive heart failure requiring hospitalization within the last months * Transmural myocardial infarction within the last 6 months * Acquired immune deficiency syndrome (AIDS) based upon the current CDC definition; note, however, that HIV testing is not required for entry to protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved may be significantly immunosuppressive * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration * Hepatic insufficiency resulting in jaundice and/or coagulation defects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Tumor Control Rate, as Measured From the Time of Treatment Completion Until the First Documented Date of Local Failure | At 12 months following chemo/radiation therapy | Primary tumor control rate at 12 months, as well its 95% confidence interval, will be reported for all eligible subjects received treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability Measured by the Number of Patients Who Discontinue Treatment | Up to 5 years | The number of patients who discontinue treatment will be summarized. |
| Regional Control | Up to 24 months | Regional control rate at 24 months will be reported for all eligible patients who received treatment. |
| Distant Control | Up to 24 months | Distant control rate at 24 months will be reported for all eligible patients who received treatment |
| Disease-free Survival (DFS) | From date of treatment initiation to progression, assessed up to 24 months | Kaplan-Meier (K-M) analysis will be used to estimate DFS. |
| Overall Survival (OS) | Up to 24 months | K-M analysis will be used to estimate OS. |
| Number of Adverse Events | Up to 30 days after completion of treatment, up to 5 years | Number of all adverse events with special attention to grade 3-5 esophagitis, pneumonitis, and cardiac adverse events as defined by the National Cancer Institution Common Terminology Criteria for Adverse Events CTCAE version 5.0 |
| Changes in Tumor Perfusion Measured by MR-DCE/PWI Amp and Kep | Baseline to the end of week 1 | Changes in perfusion will be tested by comparing mean values pre- and post-hypofractionated boost radiation using a paired t-test. The following pharmacokinetic parameters will be used (parameters were derived using the modified Brix's model): Amp, Kep. |
| Changes in Tumor Perfusion Measured by MR-DCE/PWI Kpe and Kel | Baseline to the end of week 1 | Changes in perfusion will be tested by comparing mean values pre- and post-hypofractionated boost radiation using a paired t-test. The following pharmacokinetic parameters will be used (parameters were derived using the modified Brix's model): Kpe, Kel. |
| Changes in Diffusion Measured by MR-diffusion | Baseline to the end of week 1 | Changes in diffusion will be tested by comparing mean values of Apparent Diffusion Coefficient (ADC \[× 10-3 mm2/s\]) pre- and post-hypofractionated boost radiation using a paired t-test. |
| Changes in Hypoxia Measured by BOLD Sequences | Baseline to the end of week 1 | Changes in hypoxia will be tested by comparing mean values pre- and post-hypofractionated boost radiation using a paired t-test. |
| Objective Response Rate as Measured by Response Evaluation Criteria in Solid Tumors Criteria | At 3 months and 6 months | Objective response rate will be reported for all eligible patients who receive treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) Patients undergo hypofractionated radiation boost over 2 fractions (at least 40 hours apart) during week 1. Beginning week 2, patients receive cisplatin IV on days 8, 15, 36, and 43; and etoposide IV over 60 minutes on days 8-12 and 36-40. Patients also undergo standard 3-D conformal radiation therapy QD 5 days a week for a total of 30 fractions. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
hypofractionated radiation therapy: Radiation boost in week 1 (days 1-5)
cisplatin: Given IV
etoposide: Given IV
3-dimensional conformal radiation therapy: Undergo 3-dimensional conformal radiation therapy
laboratory biomarker analysis: Correlative studies | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 16 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Treatment (Hypofractionated Radiation Boost, Chemoradiation) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 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 | 18 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 16 / 21 |
| other Total, other adverse events | 21 / 21 |
| serious Total, serious adverse events | 9 / 21 |
Outcome results
Primary
Primary Tumor Control Rate, as Measured From the Time of Treatment Completion Until the First Documented Date of Local Failure
Primary tumor control rate at 12 months, as well its 95% confidence interval, will be reported for all eligible subjects received treatment.
Time frame: At 12 months following chemo/radiation therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Primary Tumor Control Rate, as Measured From the Time of Treatment Completion Until the First Documented Date of Local Failure | 100 percentage of participants |
Secondary
Changes in Diffusion Measured by MR-diffusion
Changes in diffusion will be tested by comparing mean values of Apparent Diffusion Coefficient (ADC \[× 10-3 mm2/s\]) pre- and post-hypofractionated boost radiation using a paired t-test.
Time frame: Baseline to the end of week 1
Population: The functional MRI substudies that measured changes in tumor perfusion were optional for participants. Eleven participants chose to participate in the substudies.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Changes in Diffusion Measured by MR-diffusion | 23 percentage of change | Standard Deviation 52.4 |
Secondary
Changes in Hypoxia Measured by BOLD Sequences
Changes in hypoxia will be tested by comparing mean values pre- and post-hypofractionated boost radiation using a paired t-test.
Time frame: Baseline to the end of week 1
Population: The functional MRI substudies that measured changes in tumor perfusion were optional for participants. Eleven participants chose to participate in the substudies.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Changes in Hypoxia Measured by BOLD Sequences | -87.1 percentage of change | Standard Deviation 144.7 |
Secondary
Changes in Tumor Perfusion Measured by MR-DCE/PWI Amp and Kep
Changes in perfusion will be tested by comparing mean values pre- and post-hypofractionated boost radiation using a paired t-test. The following pharmacokinetic parameters will be used (parameters were derived using the modified Brix's model): Amp, Kep.
Time frame: Baseline to the end of week 1
Population: The functional MRI substudies that measured changes in tumor perfusion were optional for participants. Eleven participants chose to participate in the substudies.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Changes in Tumor Perfusion Measured by MR-DCE/PWI Amp and Kep | Changes in Kep | 2.9 percentage of change | Standard Deviation 47 |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Changes in Tumor Perfusion Measured by MR-DCE/PWI Amp and Kep | Changes in Amp | -6.8 percentage of change | Standard Deviation 22.9 |
Secondary
Changes in Tumor Perfusion Measured by MR-DCE/PWI Kpe and Kel
Changes in perfusion will be tested by comparing mean values pre- and post-hypofractionated boost radiation using a paired t-test. The following pharmacokinetic parameters will be used (parameters were derived using the modified Brix's model): Kpe, Kel.
Time frame: Baseline to the end of week 1
Population: The functional MRI substudies that measured changes in tumor perfusion were optional for participants. Eleven participants chose to participate in the substudies.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Changes in Tumor Perfusion Measured by MR-DCE/PWI Kpe and Kel | Changes in Kpe | 5.1 percentage of change |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Changes in Tumor Perfusion Measured by MR-DCE/PWI Kpe and Kel | Changes in Kel | -4.5 percentage of change |
Secondary
Disease-free Survival (DFS)
Kaplan-Meier (K-M) analysis will be used to estimate DFS.
Time frame: From date of treatment initiation to progression, assessed up to 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Disease-free Survival (DFS) | 46.1 percentage of participants |
Secondary
Distant Control
Distant control rate at 24 months will be reported for all eligible patients who received treatment
Time frame: Up to 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Distant Control | 70.3 percentage of participants |
Secondary
Number of Adverse Events
Number of all adverse events with special attention to grade 3-5 esophagitis, pneumonitis, and cardiac adverse events as defined by the National Cancer Institution Common Terminology Criteria for Adverse Events CTCAE version 5.0
Time frame: Up to 30 days after completion of treatment, up to 5 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Fall | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Fever (Max 100.8) | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Fibrosis deep connective tissue | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Pericardial effusion | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Peripheral motor neuropathy | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Peripheral sensory neuropathy | 4 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Bronchial obstruction | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Bronchial stricture | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Bruising- Lt rib area | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Chest wall pain | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Chills | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Confusion | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Constipation | 6 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Cough, intermittent | 4 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Cushingoid, face | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Dehydration | 7 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Dermatitis Radiation (to upper back and skin darkening to the underside of right breast) | 15 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Diarrhea | 6 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Dizziness | 6 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Dysgeusia | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Dyspepsia | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Dysphagia | 14 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Dyspnea | 7 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Dyspnea and cough | 3 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Ear and labyrinth disorders- Other, Chronic otomastoiditis- bilateral | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Epistaxis | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Esophageal pain- odynophagia | 3 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Esophageal stenosis | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Esophagitis | 14 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Flushing | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Fracture- left rib | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Gastritis | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Gastroesophageal reflux disease (GERD) | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Gastrointestinal disorders- Other- Perirectal abscess | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Headache | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Hematuria | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Hiccups | 3 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Hoarseness | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Hyperglycemia | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Hyperkalemia | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Hypernatremia | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Hyperpigmentation- left chest (red discoloration) | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Hypertension- intermittent | 3 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Hypoalbuminemia | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Hypocalcemia (uncorrected- 8.3) | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Hypokalemia (3.3) | 5 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Hypomagnesemia (1.5) | 4 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Hyponatremia | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Hypophosphatemia | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Hypotension- orthostatic | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Hypothyroidism | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Hypoxia | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Infections and infestations- Other- Bacteremia | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Infusion related reaction during Paclitaxel infusion | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Infusion site reaction- right forearm- General disorders other | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Insomnia | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Localized edema- left chest wall | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Lung infection-pneumonia | 5 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Lymphocyte Count Decreased | 19 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Mucosal infection- mouth thrush | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Musculoskeletal and connective tissue disorder- Other, right paraspinal muscle spasm | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Mucositis oral- mouth sore | 3 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Myalgia | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Nasal congestion | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Nausea | 10 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Nervous system disorders- Other, increased sense of smell, intermittent | 4 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Neutrophil count decreased | 9 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Non-cardiac chest pain | 4 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Pain in extremity- both hands due to arthritis | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Pain- back | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Pain-ribs | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Palpitation | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Paresthesia- both lower extremities | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Platelet count decreased | 11 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Pleural effusion | 5 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Pleuritic pain, intermittent (Rt below breast) | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Pneumonitis, radiation related | 8 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Abdominal Pain | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Activated partial thromboplastin time prolonged | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Acute kidney injury | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Adrenal insufficiency | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Alanine aminotransferase increased | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Alopecia | 11 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Anemia | 14 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Anorexia | 7 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Aortic valve disease | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Arthralgia | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Aspartate aminotransferase increased | 3 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Bloating | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Blood and lymphatic system disorders- Other, coagulation | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Blurred vision | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Bronchial infection | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Pruritis (back) | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Pulmonary fibrosis | 9 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Productive cough | 7 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Proteinuria | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Rash- maculo-papular- back/chest | 3 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Respiratory failure | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Respiratory, mediastinal and thoracic disorders- Other- COPD | 4 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Sebaceous cyst on the back | 3 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Sepsis | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Sinus bradycardia | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Sinus tachycardia | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Skin infection- gluteal cleft | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Sore throat | 3 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Syncope | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Tachycardia- intermittent | 3 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Tinnitus- both ears | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Tremor | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Upper respiratory infection | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Urinary Tract Infection- Pyelonephritis | 2 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Vomiting- intermittent | 9 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Weight gain | 1 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Weight loss | 7 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Wheezing | 6 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | White blood cell count decreased | 17 Number of Events |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Number of Adverse Events | Fatigue | 11 Number of Events |
Secondary
Objective Response Rate as Measured by Response Evaluation Criteria in Solid Tumors Criteria
Objective response rate will be reported for all eligible patients who receive treatment.
Time frame: At 3 months and 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Objective Response Rate as Measured by Response Evaluation Criteria in Solid Tumors Criteria | At 3 months | 72.7 percentage of participants |
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Objective Response Rate as Measured by Response Evaluation Criteria in Solid Tumors Criteria | At 6 months | 80.0 percentage of participants |
Secondary
Overall Survival (OS)
K-M analysis will be used to estimate OS.
Time frame: Up to 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Overall Survival (OS) | 50.3 percentage of participants |
Secondary
Regional Control
Regional control rate at 24 months will be reported for all eligible patients who received treatment.
Time frame: Up to 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Regional Control | 81.6 percentage of participants |
Secondary
Tolerability Measured by the Number of Patients Who Discontinue Treatment
The number of patients who discontinue treatment will be summarized.
Time frame: Up to 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Hypofractionated Radiation Boost, Chemoradiation) | Tolerability Measured by the Number of Patients Who Discontinue Treatment | 0 participants |