SWOG clinical trial number
S1505
A Randomized Phase II Study of Perioperative mFOLFIRINOX versus Gemcitabine/nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma
Closed
Phase
Accrual
98%
Abbreviated Title
Perioperative FOLFIRINOX vs Gem/nab-Pac for Resectable Panc Adeno
Status Notes
S1505 is now closed to accrual as of 04/20/2018.
Activated
10/12/2015
Participants
ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
Research committees
Gastrointestinal Cancer
Treatment
5-Fluorouracil
Gemcitabine hydrochloride
Irinotecan
Leucovorin Calcium
Oxaliplatin
Surgery
Nab-Paclitaxel
Eligibility Criteria Expand/Collapse
Pts must have histologically or cytologically proven pancreatic adenocarcinoma. Pts must have measurable disease in the pancreas within 28 days prior to reg. Pts must have resectable primary tumor based on contrast-enhanced CT or MRI of the chest, abdomen, and pelvis. CT scans or MRIs used to assess disease must be submitted for central review.
The local interpreting radiologist
must review the scans and sign the S1505 Local Radiology Review Checklist prior to
registration. Pts must have surgical consult to verify pt is a surgical candidate within 21 days prior to reg. Pts must not have received prior surgery, radiation therapy, chemotherapy, targeted therapy, or any investigational therapy for pancreatic cancer. Pts must have Zubrod PS of 0-1. Pts must be 18-75 years old. Pts must have adequate hematologic function w/in 14 days prior to reg: ANC >/= 2265 1,500/mcL, platelets >/= 100,000/mcL, and hemoglobin >/= 9 g/dL. Pts must have adequate hepatic function w/in 14 days prior to reg: total bilirubin </= 1.5xIULN, AST and ALT </= 2.5xIULN, and serum albumin >/= 3 g/dL. Pts must have adequate kidney function w/in 14 days prior to reg: serum creatinine </= IULN. Pts 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 are not eligible. No prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease and treatment-free for two years. Pts must not be pregnant or nursing for up to 3 months after final administered dose of chemotherapy.
The local interpreting radiologist
must review the scans and sign the S1505 Local Radiology Review Checklist prior to
registration. Pts must have surgical consult to verify pt is a surgical candidate within 21 days prior to reg. Pts must not have received prior surgery, radiation therapy, chemotherapy, targeted therapy, or any investigational therapy for pancreatic cancer. Pts must have Zubrod PS of 0-1. Pts must be 18-75 years old. Pts must have adequate hematologic function w/in 14 days prior to reg: ANC >/= 2265 1,500/mcL, platelets >/= 100,000/mcL, and hemoglobin >/= 9 g/dL. Pts must have adequate hepatic function w/in 14 days prior to reg: total bilirubin </= 1.5xIULN, AST and ALT </= 2.5xIULN, and serum albumin >/= 3 g/dL. Pts must have adequate kidney function w/in 14 days prior to reg: serum creatinine </= IULN. Pts 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 are not eligible. No prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease and treatment-free for two years. Pts must not be pregnant or nursing for up to 3 months after final administered dose of chemotherapy.
Publication Information Expand/Collapse
2024
PMid: PMID38688309
2023
2021
PMid: PMID33475684 | PMC number: PMC7821078
2020
2019
2018
2017
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Accrual
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