Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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European Study Group For Pancreatic Cancer - Trial 3

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: fluorouracil
* Drug: gemcitabine hydrochloride
* Drug: leucovorin calcium
* Other: clinical observation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I<br>Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5. | Drug: fluorouracil<br>* Given IV<br>Drug: leucovorin calcium<br>* Given IV<br>|
| Experimental: Arm II<br>Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. | Drug: gemcitabine hydrochloride<br>* Given IV<br>|
| No Intervention: Arm III<br>Patients undergo observation. | Other: clinical observation<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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