European Study Group For Pancreatic Cancer - Trial 3
- 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.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life and 5-year survival of patients treated with these
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
- 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
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.
Allocation: Randomized, Primary Purpose: Treatment
John P. Neoptolemos, MD
Royal Liverpool University Hospital
United States: Federal Government