Combination Chemotherapy With or Without Hypofractionated Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer

Status unconfirmed · Phase 2

Conditions studied: Pancreatic Adenocarcinoma, Borderline Resectable Adenocarcinoma of the Head of the Pancrease

In brief

This randomized phase II trial studies how well combination chemotherapy (mFOLFIRINOX) with or without hypofractionated radiation therapy before surgery works in patients with pancreatic cancer that can be removed by surgery. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, and irinotecan hydrochloride, 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. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. It is not yet known if combination chemotherapy is more effective with or without hypofractionated radiation therapy before surgery in treating patients with pancreatic cancer.

Key facts

Study ID

NCT02839343

Run by

Alliance for Clinical Trials in Oncology

People needed

126

Starts

2016-12-01

Last updated by the study team

2022-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmation of radiographic stage as borderline resectable disease by real-time Alliance central radiographic review
• No prior chemotherapy or radiation for pancreatic cancer
• No definitive resection of pancreatic cancer
• Chronic concomitant treatment with strong inhibitors of cytochrome p450, family 3, subfamily a, polypeptide 4 gene (CYP3A4) is not allowed on this study; patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
• Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment
• No grade >= 2 neuropathy
• No known Gilbert's syndrome or known homozygosity for UGAT1A1*28 polymorphism
• No uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease) within 28 days of registration
• Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Absolute neutrophil count (ANC) >= 1,500/mm\^3
• Platelet count >= 100,000/mm\^3
• Creatinine =< 1.5 x upper limit of normal (ULN) or
• Calculated (calc.) creatinine clearance > 45 mL/min
• Total bilirubin =< 2.0 mg/dL
• Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 2.5 X upper limit of normal (ULN)

Where it is running

• Southern Cancer Center PC-Springhill — Mobile, Alabama, United States
• University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• University Oncology Associates — Clovis, California, United States
• Kaiser Permanente-Fremont — Fremont, California, United States
• Kaiser Permanente-Fresno — Fresno, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Los Angeles County-USC Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Kaiser Permanente-Modesto — Modesto, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• Kaiser Permanente-Redwood City — Redwood City, California, United States
• Kaiser Permanente-Richmond — Richmond, California, United States
• Kaiser Permanente-Roseville — Roseville, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Kaiser Permanente-South Sacramento — Sacramento, California, United States
• Kaiser Permanente - Sacramento — Sacramento, California, United States
• California Pacific Medical Center-Pacific Campus — San Francisco, California, United States
• Kaiser Permanente-San Francisco — San Francisco, California, United States
• Kaiser Permanente-Santa Teresa-San Jose — San Jose, California, United States
• Kaiser Permanente San Leandro — San Leandro, California, United States
• Kaiser Permanente-San Rafael — San Rafael, California, United States
• Southern Cancer Center PC-Mobile — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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