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| Sponsor: | Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00010062 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells left after surgery.
PURPOSE: Phase II trial to study the effectiveness of combining fluorouracil and radiation therapy in treating patients who have undergone surgery for pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: fluorouracil Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer |
| Study Start Date: | October 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive high-dose radiotherapy 5 days a week for 5 weeks. Patients also receive low-dose radiotherapy 4 times a week during the last 2 weeks of the 5-week course of treatment. Patients concurrently receive fluorouracil IV continuously for 5 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| France | |
| C.H. Senlis | |
| Senlis, France, 60309 | |
| Centre du Rouget | |
| Sarcelles, France, 95250 | |
| Centre Hospital Regional Universitaire de Limoges | |
| Limoges, France, 87042 | |
| Centre Jean Bernard | |
| Le Mans, France, 72000 | |
| Centre Medico-Chirurgical Foch | |
| Suresnes, France, 92151 | |
| Centre Regional Francois Baclesse | |
| Caen, France, 14076 | |
| CHR de Grenoble - La Tronche | |
| Grenoble, France, F-38043 | |
| Clinique Saint Vincent | |
| Saint Gregoire, France, 35700 | |
| Clinique Claude Bernard | |
| Ermont, France, 95120 | |
| Clinique De Savoie | |
| Annemasse, France, 74100 | |
| Clinique Floreal | |
| Bagnolet, France, 28630 | |
| Clinique Pasteur | |
| Toulouse, France, 31076 | |
| Clinique Pasteur | |
| Evreux, France, 27000 | |
| Clinique Saint - Jean | |
| Cagne-sur-Mer, France, 06800 | |
| CHU Pitie-Salpetriere | |
| Paris, France, 75651 | |
| Clinique Ste - Marie | |
| Pontoise, France, 95301 | |
| Clinique Tivoli | |
| Bordeaux, France, F-33030 | |
| Hopital Beaujon | |
| Clichy, France, 92118 | |
| Hopital Claude Gallien | |
| Quincy Sous Senart, France, 91480 | |
| Hopital Louis Mourier | |
| Colombes, France | |
| Hopital Fontenoy | |
| Chartres, France, 28018 | |
| Hopital Laennec | |
| Paris, France, 75007 | |
| Hopital Drevon | |
| Dijon, France, 21000 | |
| Hopital Saint - Louis | |
| La Rochelle, France, 17000 | |
| Hopital Saint Antoine | |
| Paris, France, 75571 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Polyclinique De Courlancy | |
| Reims, France, F-51100 | |
| Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie | |
| Gien, France, 45500 | |
| Polyclinique Saint Jean | |
| Cagnes Sur Mer, France | |
| Luxembourg | |
| Hopital de la Ville D'Esch-sur-Alzette | |
| Esch-sur-Alzette, Luxembourg, L-4005 | |
| Study Chair: | Jacques Balosso, MD, PhD | CHU de Grenoble - Hopital de la Tronche |
More Information
| Study ID Numbers: | CDR0000068438, FRE-GERCOR-D98-1, EU-20022 |
| Study First Received: | February 2, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00010062 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
|
Antimetabolites Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Fluorouracil Pancreatic Diseases Endocrine Gland Neoplasms |