Italian Multicenter Study Comparing FOLFOXIRI Versus Gemcitabine as Adjuvant Treatment for Resected Pancreatic Cancer

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with resected pancreatic cancer who fulfill the selection criteria will be randomized to receive one of the two treatment arms for a period of 6 months: Gemcitabine, the standard arm, or FOLFOXIRI (the combination of 5-Fluorouracil/Folinic Acid, Oxaliplatin and Irinotecan), the experimental arm.

A total of 310 patients will be enrolled in about 50 Italian centers.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana
• Treatments: Fluorouracil; Gemcitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• histological diagnosis of pancreatic cancer

• surgical resection with curative intent within 10 weeks before of enrollment (stage I-III)

• absence of evidence of metastases (cM0)

• age 18-75

• ECOG performance status 0-1

• adequate bone marrow, liver and renal function

• written informed consent

Exclusion Criteria:

• evidence of metastases

• CA19.9 higher than 2.5 x ULN (upper limit of normal range)

• precedent chemotherapy or radiotherapy

• coexisting malignancies

• relevant coexisting diseases that could contraindicate the participation to the study

• hypersensitivity/intolerance to the drugs in study

• pregnancy or breastfeeding

• neurotoxicity of grade > 1

• malabsorption syndrome