NCT00058201

Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer

European Study Group For Pancreatic Cancer - Trial 3

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,030 (estimated)
• Sponsor: Royal Liverpool University Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective, or whether chemotherapy is more effective than observation, in treating pancreatic cancer after surgery. PURPOSE: Phase III trial to compare the effectiveness of two chemotherapy regimens with no further therapy in treating patients who have completely resected pancreatic cancer.

Detailed description

OBJECTIVES: Primary * Compare the efficacy of adjuvant gemcitabine vs fluorouracil and leucovorin calcium (vs observation only in patients with ampullary or other pancreatic malignancy), in terms of overall survival, in patients with completely resected pancreatic cancer. Secondary * Compare the toxicity of these regimens in these patients. * Compare the quality of life and 5-year survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histology (ductal adenocarcinoma vs ampullary or other pancreatic malignancy), resection margin status, and participating country. Patients are randomized to 1 of 2 treatment arms. Randomization for patients with ampullary or other pancreatic malignancy includes an observation arm. * Arm I: Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5. * Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. * Arm III (patients with ampullary or other pancreatic malignancy only): Patients undergo observation. Treatment in arms I and II repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, 3, 6, and 12 months, and then annually for 5 years. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 1,030 patients with pancreatic adenocarcinoma (515 per arms I and II) will be accrued for this study.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	fluorouracil	Given IV
DRUG	gemcitabine hydrochloride	Given IV
DRUG	leucovorin calcium	Given IV
OTHER	clinical observation	No intervention

Timeline

• Start date: 2001-07-01
• Primary completion: 2008-04-01
• Completion: 2010-09-01
• First posted: 2003-04-09
• Last updated: 2013-12-18

Locations

27 sites across 13 countries: Australia, Canada, Czechia, Finland, France, Germany, Greece, Hungary, Italy, Japan, Sweden, Switzerland, United Kingdom