S1505: Combination Chemotherapy or Gemcitabine Hydrochloride and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
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.
Timeline
- Start
- 2016-01-06
- Primary completion
- 2020-05-31
- Completion
- 2022-09-26
Outcome
Missed primary endpoint
paper Neither arm's 2-year OS estimate was significantly higher than the a priori threshold of 40%. PMID 33475684 ↗
registry analysis (superiority test); mFOLFIRINOX ->Surg ->mFOLFIRINOX; p = .15; Log Rank NCT02562716 ↗
registry analysis (superiority test); Gem/Nab-P ->Surg ->Gem/Nab-P; p = .14; Log Rank NCT02562716 ↗
Publications
- Sohal DPS, Boutin RD, Lenchik L, Kim J, Beg MS, Wang-Gillam A, Wade JL 3rd, Guthrie KA, Chiorean EG, Ahmad SA, Lowy AM, Philip PA, Chang VT. Body composition measurements and clinical outcomes in patients with resectable pancreatic adenocarcinoma - analysis from SWOG S1505. J Gastrointest Surg. 2024 Mar;28(3):232-235. doi: 10.1016/j.gassur.2023.12.022. Epub 2024 Jan 19.
- Sohal DPS, Duong M, Ahmad SA, Gandhi NS, Beg MS, Wang-Gillam A, Wade JL 3rd, Chiorean EG, Guthrie KA, Lowy AM, Philip PA, Hochster HS. Efficacy of Perioperative Chemotherapy for Resectable Pancreatic Adenocarcinoma: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021 Mar 1;7(3):421-427. doi: 10.1001/jamaoncol.2020.7328.
- Ahmad SA, Duong M, Sohal DPS, Gandhi NS, Beg MS, Wang-Gillam A, Wade JL 3rd, Chiorean EG, Guthrie KA, Lowy AM, Philip PA, Hochster HS. Surgical Outcome Results From SWOG S1505: A Randomized Clinical Trial of mFOLFIRINOX Versus Gemcitabine/Nab-paclitaxel for Perioperative Treatment of Resectable Pancreatic Ductal Adenocarcinoma. Ann Surg. 2020 Sep 1;272(3):481-486. doi: 10.1097/SLA.0000000000004155.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | — | Intravenous |
| Subject | Irinotecan | Small molecule | — | Intravenous |
| Subject | Oxaliplatin | Small molecule | — | Intravenous |
| Subject | Paclitaxel Albumin-Stabilized Nanoparticle Formulation | Unknown | — | Intravenous |
| Subject | fluorouracil | Small molecule | — | Intravenous |