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
II
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.

Publication Information Expand/Collapse

2021

Efficacy of Perioperative Chemotherapy for Resectable Pancreatic Adenocarcinoma: A Phase 2 Randomized Clinical Trial

D Sohal;M Duong;S Ahmad;N Gandhi;S Beg;A Wang-Gillam;JL Wade;EG Chiorean;K Guthrie;A Lowy;P Philip;H Hochster JAMA Oncology Jan 21;e207328. doi: 10.1001/jamaoncol.2020.7328. Online ahead of print

Immunologic Predictors of Therapeutic Response to Neoadjuvant Therapy for Pancreatic Adenocarcinoma (PDA) in SWOG S1505

D Sohal;M Duong;R Chang;Y Xue;D Delman;I Garrido-Laguna;S Mulvihill;K Affolter;MK Washington;MS Beg;A Wang-Gillam;J Wade;N Gandhi;S Ahmad;A Lowy;EG Chiroean;K Guthrie;H Hochster;PA Philip;G Beatty J Clin Oncol 39, 2021 (suppl 3; abstr 419); ASCO GI Cancers Symposium (January 15-17, 2021, virtual), Poster Presentation and Poster Highlights session

2020

SWOG S1505: Initial Surgical Outcome Results from a Randomized Clinical Trial of mFOLFIRINOX vs. Gemcitabine/nab-Paclitaxel for Perioperative Treatment of Resectable Pancreatic Ductal Adenocarcinoma (PDA)

S Ahmad;M Duong;D Sohal;N Ghandi;MS Beg;A Wang-Gillam;J Wade;K Guthrie;A Lowy;PA Philip;H Hochster American Surgical Association Annual Meeting (April 16-18, 2020, Washington, DC), oral presentation

SWOG S1505: Results of Perioperative Chemotherapy with mFOLFIRINOX versus Gemcitabine/nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma

D Sohal;M Duong;S Ahmad;N Gandhi;MS Beg;A Wang-Gillam;JL Wade, III;E Chiorean;K Guthrie;A Lowy;PA Philip;H Hochster J Clin Oncol 38: 2020 (suppl; abstr 4504); American Society of Clinical Oncology Annual Meeting (5/29/2020 - 6/2/2020, Chicago, IL), oral

Surgical Outcome Results from SWOG S1505: A Randomized Clinical Trial of mFOLFIRINOX vs. Gemcitabine/nab-Paclitaxel for Perioperative Treatment of Resectable Pancreatic Ductal Adenocarcinoma (PDA)

S Ahmad;M Duong;D Sohal;N Gandhi;S Beg;A Wang-Gillam;J Wade;E Chiorean;K Guthrie;A Lowy;P Philip;H Hochster Annals of Surgery Sep 1;272(3):481-486

PMid: PMID32740235 | PMC number: PMC7856053

2019

SWOG S1505: Initial Findings on Eligibility and Neoadjuvant Chemotherapy Experience with mFOLFIRINOX versus Gemcitabine/nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma

DPS Sohal;S McDonough;S Ahmad;N Gandhi;M Shaalan Beg;A Wang-Gillam;TBA;JL Wade, III;K Guthrie;A Lowy;P Philip;H Hochster J Clin Oncol 37, 2019 (suppl 4; abstr 414); ASCO GI Cancers Symposium (Jan 17-19, 2019, San Francisco, CA), poster

SWOG S1505: Initial Findings on Eligibility and Neoadjuvant Chemotherapy Experience with mFOLFIRINOX versus Gemcitabine/nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma

D Sohal;D Lew;S Ahmad;N Gandhi;S Beg;A Wang-Gillam;J Wade;K Guthrie;A Lowy;P Philip;H Hochster J Clin Oncol 37(suppl; abstr 4137); American Society of Clinical Oncology (5/31/19 - 6/4/19, Chicago IL), poster session

2018

SWOG S1505: A Randomized Phase II Study of Perioperative mFOLFIRINOX vs. Gemcitabine/nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma

D Sohal;S McDonough;SA Ahmad;N Gandhi;MS Beg;A Wang-Gillam;KA Guthrie;AM Lowy;PA Philip;H Hochster Journal of Clinical Oncology 36 (suppl 4S; abstr TPS547); ASCO Gastrointestinal Cancers Symposium 2018 (January 18-20, 2018, San Francisco, CA), poster

SWOG S1505: A Randomized Phase II Study of Perioperative mFOLFIRINOX vs. Gemcitabine/nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma

D Sohal;S McDonough;S Ahmad;N Gandhi;MS Beg;A Wang-Gillam;K Guthrie;A Lowy;P Philip;H Hochster J Clin Oncol 36, 2018 (suppl; abstr TPS4153); ASCO Annual Meeting (June 1- 5, 2018, Chicago, IL), poster session

2017

SWOG S1505: a randomized phase II study of peri-operative mFOLFIRINOX vs. gmcitabine/nab-paclitaxel as therapy for resectable pancreatic adenocarcinoma

D Sohal;S McDonough;S Ahmad;N Gandhi;M Beg;A Wang-Gillam;K Guthrie;A Lowy;P Philip;H Hochster J Clin Oncol 35, 2017 (suppl 4S; abstract TPS508); ASCO GI Cancers Symposium (January 19-21, 2017, San Francisco, CA), poster, abst. #TPS508

SWOG S1505: A randomized phase II study of perioperative mFOLFIRINOX vs. gemcitabine/nab-paclitaxel as therapy for resectable pancreatic adenocarcinoma

S Ahmad;S McDonough;DPS Sohal;N Gandhi;M Beg;A Wang Gillam;K Guthrie;A Lowy;PA Philip;H Hochster American Hepato-Panreato-Biliary Association Annual Meeting (March 29-April 2, 2017, Miami Beach, Florida), oral

2016

SWOG S1505: A randomized phase II study of perioperative mFOLFIRINOX versus Gemcitabine/nab-Paclitaxel as therapy for resectable pancreatic adenocarcinoma

D Sohal;K Guthrie;S Ahmad;N Gandhi;M Shaalan Beg;A Wang Gillam;S McDonough;A Lowy;P Philip;H Hochster Journal of Clinical Oncology 34, 2016 (suppl; abstr TPS4151); American Society of Clinical Oncology Annual Meeting (June 3-7, 2016, Chicago, IL) TIP, poster session

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CTSU/EA2176
SWOG Clinical Trial Number
CTSU/A021806

A Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer

Research Committee(s)
Gastrointestinal Cancer
Activated
07/01/2020
Open