Perioperative Chemotherapy for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, 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 chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).
Will I have to stop taking my current medications?
The trial requires that you stop taking any strong inhibitors or inducers of CYP3A4 (a liver enzyme that affects drug metabolism) before joining. If you're on these medications, you'll need to discontinue them prior to registration.
Is perioperative chemotherapy for pancreatic cancer safe for humans?
The combination of drugs used in perioperative chemotherapy for pancreatic cancer, such as 5-fluorouracil, irinotecan, leucovorin, and oxaliplatin, has been studied for safety. While these treatments can be effective, they are known to have significant side effects, which can sometimes lead to stopping the treatment or making surgery unsuitable for some patients.12345
How does the perioperative chemotherapy treatment for pancreatic cancer differ from other treatments?
This treatment uses a combination of drugs known as mFOLFIRINOX, which includes 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin, and is preferred worldwide for its reduced toxicity and better tolerance compared to other regimens. It is unique because it is used both before and after surgery (perioperative), which can help shrink the tumor before surgery and kill remaining cancer cells after surgery.678910
What data supports the effectiveness of the drug FOLFIRINOX for pancreatic cancer?
Who Is on the Research Team?
Cristina R. Ferrone, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for adults with removable pancreatic cancer who have not had prior treatments. They must have normal bilirubin and creatinine levels or adequate kidney function, no severe liver conditions like Gilbert's Syndrome, and be fit for surgery. Pregnant or nursing women can't join, nor those on certain drugs affecting the liver enzyme CYP3A4. Participants need to be in good physical condition (ECOG 0-1) with minimal nerve damage from neuropathy.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Chemotherapy
Patients receive mFOLFIRINOX chemotherapy before surgery for 8 cycles
Surgery
Patients undergo surgical resection of the pancreatic tumor
Adjuvant Chemotherapy
Patients receive mFOLFIRINOX chemotherapy after surgery for 4 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Fluorouracil
- Irinotecan Hydrochloride
- Leucovorin Calcium
- Oxaliplatin
- Resection
Fluorouracil is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator