Pancreatic Adenocarcinoma, Resectable Pancreatic Carcinoma
Conditions
Brief summary
This randomized phase II trial studies how well fluorouracil, irinotecan hydrochloride, and oxaliplatin (combination chemotherapy) works and compares to gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating patients with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, oxaliplatin, gemcitabine hydrochloride, and paclitaxel albumin-stabilized nanoparticle formulation, 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective than gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating pancreatic cancer.
Detailed description
PRIMARY OBJECTIVES: I. To assess 2-year overall survival in each treatment arm (fluorouracil, irinotecan hydrochloride, and oxaliplatin \[modified (m)FOLFIRINOX\] and gemcitabine \[gemcitabine hydrochloride\]/nab-paclitaxel \[paclitaxel albumin-stabilized nanoparticle formulation\]) in patients with resectable pancreatic cancer. II. If the stated threshold is met in one or both arms: to choose the better regimen with respect to 2-year overall survival. SECONDARY OBJECTIVES: I. To estimate, for all patients and within treatment arms: frequency and severity of adverse events associated with chemotherapy in the perioperative setting. II. To estimate, for all patients and within treatment arms: proportion of patients going to surgery for resection after preoperative chemotherapy. III. To estimate, for all patients and within treatment arms: proportion of patients achieving macroscopically complete tumor removal with negative microscopic surgical margins (R0) resection after preoperative chemotherapy. IV. To estimate, for all patients and within treatment arms: overall response rate following preoperative chemotherapy, including confirmed and unconfirmed, complete and partial response, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. V. To estimate, for all patients and within treatment arms: pathologic response rates after R0 or macroscopically complete tumor removal with any positive microscopic surgical margin (R1) resection. VI. To estimate, for all patients and within treatment arms: patterns of recurrence (loco-regional, distant) after R0 or R1 resection. VII. To estimate, for all patients and within treatment arms: disease-free survival from the time of R0 or R1 resection. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oxaliplatin intravenously (IV) over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment 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 2 years.
Interventions
DRUGFluorouracil
Given IV
DRUGGemcitabine Hydrochloride
Given IV
DRUGIrinotecan Hydrochloride
Given IV
DRUGOxaliplatin
Given IV
DRUGPaclitaxel Albumin-Stabilized Nanoparticle Formulation
Given IV
PROCEDUREPancreatectomy
Undergo pancreatectomy
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients must have histologically or cytologically proven pancreatic adenocarcinoma; histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible * Patients must have measurable disease in the pancreas; computed tomography (CT) scans or magnetic resonance imaging (MRIs) used to assess measurable disease must have been completed within 28 days prior to registration; all disease must be assessed and documented on the baseline tumor assessment form * Patients must have resectable primary tumor based on contrast-enhanced CT or MRI (CT or MRI without contrast as part of positron emission tomography \[PET\]/CT or PET/MRI is NOT acceptable; CT or MRI with contrast as part of PET/CT or PET/MRI is acceptable) of the chest, abdomen, and pelvis, where resectable is defined as: * No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (and, if present, replaced right hepatic artery) * No involvement, or \< 180° interface between tumor and vessel wall, of the portal vein and/or superior mesenteric vein; and patent portal vein/splenic vein confluence * No evidence of metastatic disease * Note: for tumors of the body and tail of the pancreas, involvement of the splenic artery and vein of any degree is considered resectable disease * CT scans or MRIs used to assess disease at baseline must be submitted for central review * Patients must have surgical consult to verify patient is a surgical candidate within 21 days prior to registration * Patients must not have received prior surgery, radiation therapy, chemotherapy, targeted therapy, or any investigational therapy for pancreatic cancer * Patients must have a Zubrod performance status of 0-1 * Absolute neutrophil count (ANC) \>= 1,500/mcL * Platelets \>= 100,000/mcL * Hemoglobin \>= 9 g/dL * Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x IULN * Serum albumin \>= 3 g/dL * Serum creatinine =\< IULN within 14 days prior to registration * Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements will NOT be eligible * No prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer, in situ breast (ductal or lobular) cancer, or other cancer for which the patient has been disease and treatment-free for two years * Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method for up to 3 months after the final administered dose of chemotherapy; a woman is considered to be of reproductive potential if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, effective contraception also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures, he/she is responsible for beginning contraceptive measures * Sites must seek additional patient consent for the future use of specimens * Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to 4 years for the estimates of median overall survival. Up to 2 years for Statistical Analysis 1 and 2, comparing the observed 2-year overall survival (OS) to the null hypothesis of 40%, in each arm. | OS is the length of time between protocol registration and patient death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Going to Surgery for Resection After Preoperative Chemotherapy. | Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy). | — |
| Number of Patients Achieving R0 Resection After Preoperative Chemotherapy. | Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy). | R0 resection classification is defined as macroscopically complete tumor removal with negative microscopic surgical margins (bile duct, pancreatic parenchyma, and superior mesenteric artery margins). |
| Number of Participants With a Response Following Preoperative Chemotherapy, Including Confirmed and Unconfirmed, Complete and Partial Response, Per RECIST 1.1. | Up to 6 months post registration (and within 2 to 4 weeks after the last dose of Cycle 3 preoperative chemotherapy.). | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Duration of treatment and follow up until death or 4 years post registration. | Only adverse events that are possibly, probably or definitely related to preoperative and postoperative chemotherapy are reported. |
| Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection. | Up to 4 years | Loco-regional recurrence is defined as any evidence of new disease within the pancreatic tumor bed based on surveillance scans. The pancreatic tumor bed includes: 1. Superior mesenteric artery and vein lymph nodes 2. Lymph nodes in porta hepatis (bile duct, portal vein, hepatic artery lymph nodes) 3. Lymph nodes around left renal vein, inferior vena cava or aorta 4. Celiac axis lymph nodes. Distant Recurrence is defined as any evidence of new disease outside the primary tumor bed (liver, lungs, etc.) based on surveillance scans. |
| Disease-free Survival From the Time of R0 or R1 Resection. | Up to 4 years | Disease-free survival (DFS) is calculated for patients who undergo surgical resection (R0/R1). DFS will be measured from the date of surgical resection to date of first documentation of recurrence (loco-regional or distant) or death due to any cause. Patients last known to be alive and free of disease will be censored at date of last contact. |
| Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection. | Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy). | Pathologic response was evaluated after the patient had surgery, and was based on local pathology review of the resected surgical specimen, according to the following Tumor Regression Grade definitions: 0: Complete response - no residual tumor 1. Moderate response - minimal residual cancer (single cells or small groups of cancer cells) 2. Minimal response - residual cancer outgrown by fibrosis 3. Poor or no response - no definite response identified (minimal or no tumor kill; extensive residual cancer) |
Countries
United States
Participant flow
Pre-assignment details
147 participants were randomized, but 43 were found to be ineligible per central radiology review, and 1 was found to be ineligible due to incorrect primary tumor. One patient withdrew study consent prior to any therapy and was not evaluable. Therefore 102 were deemed eligible and analyzable for the primary analysis.
Participants by arm
| Arm | Count |
|---|---|
| mFOLFIRINOX ->Surg ->mFOLFIRINOX Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity. | 55 |
| Gem/Nab-P ->Surg ->Gem/Nab-P Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity. | 47 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 14 |
| Overall Study | Death | 2 | 1 |
| Overall Study | Not protocol specified | 4 | 2 |
| Overall Study | Progression | 8 | 10 |
| Overall Study | Withdrawal unrelated to AE | 7 | 1 |
Baseline characteristics
| Characteristic | mFOLFIRINOX ->Surg ->mFOLFIRINOX | Total | Gem/Nab-P ->Surg ->Gem/Nab-P |
|---|---|---|---|
| Age, Continuous | 66 years | 64 years | 64 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 7 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants | 94 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) White | 52 Participants | 91 Participants | 39 Participants |
| Sex: Female, Male Female | 19 Participants | 42 Participants | 23 Participants |
| Sex: Female, Male Male | 36 Participants | 60 Participants | 24 Participants |
| Zubrod Performance Status 0 | 34 Participants | 65 Participants | 31 Participants |
| Zubrod Performance Status 1 | 21 Participants | 37 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 32 / 55 | 32 / 47 |
| other Total, other adverse events | 53 / 53 | 45 / 45 |
| serious Total, serious adverse events | 3 / 53 | 5 / 45 |
Outcome results
Primary
Overall Survival (OS)
OS is the length of time between protocol registration and patient death
Time frame: Up to 4 years for the estimates of median overall survival. Up to 2 years for Statistical Analysis 1 and 2, comparing the observed 2-year overall survival (OS) to the null hypothesis of 40%, in each arm.
Population: Eligible and analyzable participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Overall Survival (OS) | 23.2 Months |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Overall Survival (OS) | 23.6 Months |
Comparison: For each arm, the observed 2-year overall survival (OS) was compared to the null hypothesis of 40%, assuming a 58% alternative hypothesis, 88% power, and a 1-sided significance of 0.05.p-value: 0.15Log Rank
Comparison: For each arm, the observed 2-year overall survival (OS) was compared to the null hypothesis of 40%, assuming a 58% alternative hypothesis, 88% power, and a 1-sided significance of 0.05.p-value: 0.14Log Rank
Secondary
Disease-free Survival From the Time of R0 or R1 Resection.
Disease-free survival (DFS) is calculated for patients who undergo surgical resection (R0/R1). DFS will be measured from the date of surgical resection to date of first documentation of recurrence (loco-regional or distant) or death due to any cause. Patients last known to be alive and free of disease will be censored at date of last contact.
Time frame: Up to 4 years
Population: Eligible and analyzable participants undergoing surgical resection.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Disease-free Survival From the Time of R0 or R1 Resection. | 10.9 Months |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Disease-free Survival From the Time of R0 or R1 Resection. | 14.2 Months |
Secondary
Number of Participants With a Response Following Preoperative Chemotherapy, Including Confirmed and Unconfirmed, Complete and Partial Response, Per RECIST 1.1.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 6 months post registration (and within 2 to 4 weeks after the last dose of Cycle 3 preoperative chemotherapy.).
Population: Eligible and analyzable participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Participants With a Response Following Preoperative Chemotherapy, Including Confirmed and Unconfirmed, Complete and Partial Response, Per RECIST 1.1. | 5 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Participants With a Response Following Preoperative Chemotherapy, Including Confirmed and Unconfirmed, Complete and Partial Response, Per RECIST 1.1. | 10 Participants |
Secondary
Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection.
Pathologic response was evaluated after the patient had surgery, and was based on local pathology review of the resected surgical specimen, according to the following Tumor Regression Grade definitions: 0: Complete response - no residual tumor 1. Moderate response - minimal residual cancer (single cells or small groups of cancer cells) 2. Minimal response - residual cancer outgrown by fibrosis 3. Poor or no response - no definite response identified (minimal or no tumor kill; extensive residual cancer)
Time frame: Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).
Population: Eligible and analyzable participants undergoing resection.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection. | Complete Response | 1 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection. | Moderate Response | 9 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection. | Minimal Response | 12 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection. | Poor or No Response | 18 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection. | Poor or No Response | 10 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection. | Complete Response | 3 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection. | Minimal Response | 10 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection. | Moderate Response | 10 Participants |
Secondary
Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection.
Loco-regional recurrence is defined as any evidence of new disease within the pancreatic tumor bed based on surveillance scans. The pancreatic tumor bed includes: 1. Superior mesenteric artery and vein lymph nodes 2. Lymph nodes in porta hepatis (bile duct, portal vein, hepatic artery lymph nodes) 3. Lymph nodes around left renal vein, inferior vena cava or aorta 4. Celiac axis lymph nodes. Distant Recurrence is defined as any evidence of new disease outside the primary tumor bed (liver, lungs, etc.) based on surveillance scans.
Time frame: Up to 4 years
Population: Eligible and analyzable participants undergoing resection.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection. | Loco-regional recurrence | 9 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection. | Both loco-regional and distant recurrence | 5 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection. | Distant recurrence | 13 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection. | Not assessed due to death (cardiac arrest) prior to start of post-op chemo | 0 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection. | No Progression | 13 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection. | Not assessed due to death (cardiac arrest) prior to start of post-op chemo | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection. | No Progression | 17 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection. | Loco-regional recurrence | 4 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection. | Distant recurrence | 9 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection. | Both loco-regional and distant recurrence | 2 Participants |
Secondary
Number of Patients Achieving R0 Resection After Preoperative Chemotherapy.
R0 resection classification is defined as macroscopically complete tumor removal with negative microscopic surgical margins (bile duct, pancreatic parenchyma, and superior mesenteric artery margins).
Time frame: Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).
Population: Eligible and analyzable participants undergoing surgical resection.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients Achieving R0 Resection After Preoperative Chemotherapy. | 34 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients Achieving R0 Resection After Preoperative Chemotherapy. | 28 Participants |
Secondary
Number of Patients Going to Surgery for Resection After Preoperative Chemotherapy.
Time frame: Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).
Population: Eligible and analyzable participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients Going to Surgery for Resection After Preoperative Chemotherapy. | 40 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients Going to Surgery for Resection After Preoperative Chemotherapy. | 33 Participants |
Secondary
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Only adverse events that are possibly, probably or definitely related to preoperative and postoperative chemotherapy are reported.
Time frame: Duration of treatment and follow up until death or 4 years post registration.
Population: Participants who received at least one dose of protocol treatment and were thus eligible for AE assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Aspartate aminotransferase increased | 2 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infections and infestations - Other, specify | 1 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dysesthesia | 1 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infusion related reaction | 1 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Allergic reaction | 1 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Insomnia | 0 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea | 0 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukocytosis | 1 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Biliary tract infection | 0 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lung infection | 1 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fall | 1 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphocyte count decreased | 0 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Abdominal infection | 1 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mucositis oral | 0 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue | 4 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Myocardial infarction | 1 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Blood bilirubin increased | 1 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 3 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 0 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutrophil count decreased | 11 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anemia | 4 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Non-cardiac chest pain | 0 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hepatobiliary disorders - Other, specify | 1 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pancreatitis | 1 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Colonic perforation | 0 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Papulopustular rash | 0 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyperglycemia | 2 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Peripheral motor neuropathy | 1 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Alanine aminotransferase increased | 3 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Peripheral sensory neuropathy | 5 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypertension | 0 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelet count decreased | 3 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Constipation | 0 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pneumonitis | 0 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoalbuminemia | 0 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Rectal hemorrhage | 0 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 2 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Respiratory failure | 0 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoglycemia | 0 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sepsis | 1 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dehydration | 1 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Skin infection | 1 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Acute kidney injury | 0 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thromboembolic event | 2 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypomagnesemia | 0 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vomiting | 2 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea | 8 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weight loss | 2 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyponatremia | 2 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | White blood cell decreased | 1 Participants |
| mFOLFIRINOX ->Surg ->mFOLFIRINOX | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypokalemia | 3 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | White blood cell decreased | 6 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Abdominal infection | 0 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Acute kidney injury | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Alanine aminotransferase increased | 2 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Allergic reaction | 0 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anemia | 4 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 0 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Aspartate aminotransferase increased | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Biliary tract infection | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Blood bilirubin increased | 3 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Colonic perforation | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Constipation | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dehydration | 0 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea | 3 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dysesthesia | 0 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fall | 0 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue | 3 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 2 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hepatobiliary disorders - Other, specify | 0 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyperglycemia | 2 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypertension | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoalbuminemia | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoglycemia | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypokalemia | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypomagnesemia | 2 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hyponatremia | 2 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infections and infestations - Other, specify | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infusion related reaction | 0 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Insomnia | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukocytosis | 0 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lung infection | 2 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphocyte count decreased | 2 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mucositis oral | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Myocardial infarction | 0 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutrophil count decreased | 17 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Non-cardiac chest pain | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pancreatitis | 0 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Papulopustular rash | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Peripheral motor neuropathy | 0 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Peripheral sensory neuropathy | 3 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelet count decreased | 2 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pneumonitis | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Rectal hemorrhage | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Respiratory failure | 1 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sepsis | 2 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Skin infection | 0 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thromboembolic event | 0 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vomiting | 0 Participants |
| Gem/Nab-P ->Surg ->Gem/Nab-P | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weight loss | 0 Participants |