Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer
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.
|Pancreatic Cancer||Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium Other: clinical observation||Phase 3|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||European Study Group For Pancreatic Cancer - Trial 3|
- Overall survival
- Toxicity as measured by NCI CTC v2.0
- Quality of life as measured by EORTC QLQ C-30 and ESPAC-QLQ at 3, 6, and 12 months, and then annually for 5 years
- Survival rate at 2 and 5 years
|Study Start Date:||July 2001|
|Study Completion Date:||September 2010|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I
Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5.
Given IVDrug: leucovorin calcium
Experimental: Arm II
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15.
Drug: gemcitabine hydrochloride
No Intervention: Arm III
Patients undergo observation.
Other: clinical observation
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058201
Show 27 Study Locations
|Study Chair:||John P. Neoptolemos, MD||Royal Liverpool University Hospital|
|Study Chair:||Malcolm J. Moore, MD||Princess Margaret Hospital, Canada|
|OverallOfficial:||R. Padbury||Flinders Medical Centre|
|OverallOfficial:||David Goldstein, MD||Institute of Oncology at Prince of Wales Hospital|