Spots Global Cancer Trial Database for Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer
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Trial Identification
Brief Title: Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer
Official Title: European Study Group For Pancreatic Cancer - Trial 3
Study ID: NCT00058201
Conditions
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Institute of Oncology at Prince of Wales Hospital, Randwick, New South Wales, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Cross Cancer Institute at University of Alberta, Edmonton, Alberta, Canada
British Columbia Cancer Agency - Centre for the Southern Interior, Kelowna, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Island Centre, Victoria, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
Cancer Research Institute at Queen's University, Kingston, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario, Canada
London Regional Cancer Program at London Health Sciences Centre, London, Ontario, Canada
Ottawa Hospital Regional Cancer Centre - General Campus, Ottawa, Ontario, Canada
Edmond Odette Cancer Centre at Sunnybrook, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
St. Joseph's Health Centre - Toronto, Toronto, Ontario, Canada
Hopital Charles Lemoyne, Greenfield Park, Quebec, Canada
McGill Cancer Centre at McGill University, Montreal, Quebec, Canada
Institute for Clinical and Experimental Medicine, Preha 4, , Czech Republic
Tampere University Hospital, Tampere, , Finland
Hopital Tenon, Paris, , France
Universitaets-Kinderklinik Heidelberg, Heidelberg, , Germany
Agia Olga Hospital, Athens, , Greece
Petz Aladar County Hospital, Gydr, , Hungary
Policlinico Borgo Roma, Verona, , Italy
Kyoto University Hospital, Kyoto, , Japan
Uppsala University Hospital, Uppsala, , Sweden
Inselspital Bern, Bern, , Switzerland
Royal Liverpool University Hospital, Liverpool, England, United Kingdom
Contact Details
Name: John P. Neoptolemos, MD
Affiliation: Royal Liverpool University Hospital
Role: STUDY_CHAIR
Name: Malcolm J. Moore, MD
Affiliation: Princess Margaret Hospital, Canada
Role: STUDY_CHAIR
Name: R. Padbury
Affiliation: Flinders Medical Centre
Role:
Name: David Goldstein, MD
Affiliation: Institute of Oncology at Prince of Wales Hospital
Role:
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