Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring acinar cell adenocarcinoma of the pancreas, duct cell adenocarcinoma of the pancreas, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed ductal adenocarcinoma of the pancreas OR Histologically confirmed diagnosis of 1 of the following types of cancer: Acinar cell carcinoma or cystadenocarcinoma of the pancreas Cancers of the periampullary region Cancers of the intrapancreatic part of the bile duct Periampullary cancers of uncertain origin Complete macroscopic resection (R0 or R1 resection) Histological examination of all resection margins required No stage IVB disease No evidence of malignant ascites No liver or peritoneal metastases No evidence of spread to other distant abdominal or extra-abdominal organs No pancreatic lymphoma PATIENT CHARACTERISTICS: Age 18 and over Performance status WHO 0-2 Life expectancy More than 3 months Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Not pregnant Able to participate in long-term follow-up No other prior or concurrent malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix No serious medical or psychological condition that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No neoadjuvant chemotherapy No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy Not specified Surgery See Disease Characteristics Recovered from prior resection
Sites / Locations
- Institute of Oncology at Prince of Wales Hospital
- Flinders Medical Centre
- Cross Cancer Institute at University of Alberta
- British Columbia Cancer Agency - Centre for the Southern Interior
- British Columbia Cancer Agency - Vancouver Island Centre
- CancerCare Manitoba
- Nova Scotia Cancer Centre
- Cancer Research Institute at Queen's University
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
- London Regional Cancer Program at London Health Sciences Centre
- Ottawa Hospital Regional Cancer Centre - General Campus
- Edmond Odette Cancer Centre at Sunnybrook
- Princess Margaret Hospital
- St. Joseph's Health Centre - Toronto
- Hopital Charles Lemoyne
- McGill Cancer Centre at McGill University
- Institute for Clinical and Experimental Medicine
- Tampere University Hospital
- Hopital Tenon
- Universitaets-Kinderklinik Heidelberg
- Agia Olga Hospital
- Petz Aladar County Hospital
- Policlinico Borgo Roma
- Kyoto University Hospital
- Uppsala University Hospital
- Inselspital Bern
- Royal Liverpool University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
No Intervention
Arm I
Arm II
Arm III
Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5.
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15.
Patients undergo observation.