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Sponsors and Collaborators: |
Royal Liverpool University Hospital National Cancer Institute of Canada Australasian Gastro-Intestinal Trials Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00058201 |
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.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium Procedure: observation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | European Study Group For Pancreatic Cancer - Trial 3 |
Estimated Enrollment: | 1030 |
Study Start Date: | July 2001 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5.
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Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
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Arm II: Experimental
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15.
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Drug: gemcitabine hydrochloride
Given IV
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Arm III: No Intervention
Patients undergo observation.
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Procedure: observation
No intervention
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OBJECTIVES:
Primary
Secondary
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following types of cancer:
Complete macroscopic resection (R0 or R1 resection)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | John P. Neoptolemos, MD | Royal Liverpool University Hospital |
Study Chair: | Malcolm J. Moore, MD | Princess Margaret Hospital, Canada |
Investigator: | R. Padbury | Flinders Medical Centre |
Investigator: | David Goldstein, MD | Institute of Oncology at Prince of Wales Hospital |
Study ID Numbers: | CDR0000287023, RLUH-NCRI-ESPAC-3(V2), EU-20043, CAN-NCIC-PA2, AGITG-ESPAC-3 |
Study First Received: | April 7, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00058201 |
Health Authority: | United States: Federal Government |
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 |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Leucovorin Pancrelipase Calcium, Dietary Digestive System Diseases |
Fluorouracil Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Vitamins Micronutrients |