Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00010062
First received: February 2, 2001
Last updated: February 6, 2009
Last verified: April 2007
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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 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | October 2000 |
OBJECTIVES:
- Determine the tolerance of adjuvant fluorouracil with concurrent radiotherapy in patients with resected pancreatic adenocarcinoma.
- Determine survival without local relapse in these patients treated with this regimen.
- Determine overall survival of these patients treated with this regimen.
- Determine the effectiveness of this adjuvant therapy in these patients.
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 |
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed pancreatic adenocarcinoma
- Complete macroscopic resection of tumor within past 30 days
- No residual visceral or peritoneal metastasis
- Involvement of Vater's ampulla or extrahepatic bile duct allowed
- No vesicular or intrahepatic cholangiocarcinomas
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Alkaline phosphatase less than 3 times normal
- Bilirubin less than 1.5 times normal
Renal:
- Creatinine less than 1.5 times normal
Cardiovascular:
- No serious cardiac failure
Pulmonary:
- No serious respiratory failure
Other:
- No other untreatable malignant tumors
- No serious psychological, familial, social, or geographical conditions that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for pancreatic adenocarcinoma
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy for pancreatic adenocarcinoma
- No prior radiotherapy in an anatomically proximal region to treatment area
Surgery:
- See Disease Characteristics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00010062
Locations
| France | |
| Clinique De Savoie | |
| Annemasse, France, 74100 | |
| Clinique Floreal | |
| Bagnolet, France, 28630 | |
| Clinique Tivoli | |
| Bordeaux, France, F-33030 | |
| Centre Regional Francois Baclesse | |
| Caen, France, 14076 | |
| Clinique Saint - Jean | |
| Cagne-sur-Mer, France, 06800 | |
| Polyclinique Saint Jean | |
| Cagnes Sur Mer, France | |
| Hopital Fontenoy | |
| Chartres, France, 28018 | |
| Hopital Beaujon | |
| Clichy, France, 92118 | |
| Hopital Louis Mourier | |
| Colombes, France | |
| Hopital Drevon | |
| Dijon, France, 21000 | |
| Clinique Claude Bernard | |
| Ermont, France, 95120 | |
| Clinique Pasteur | |
| Evreux, France, 27000 | |
| Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie | |
| Gien, France, 45500 | |
| CHR de Grenoble - La Tronche | |
| Grenoble, France, F-38043 | |
| Hopital Saint - Louis | |
| La Rochelle, France, 17000 | |
| Centre Jean Bernard | |
| Le Mans, France, 72000 | |
| Centre Hospital Regional Universitaire de Limoges | |
| Limoges, France, 87042 | |
| CHU Pitie-Salpetriere | |
| Paris, France, 75651 | |
| Hopital Laennec | |
| Paris, France, 75007 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Hopital Saint Antoine | |
| Paris, France, 75571 | |
| Clinique Ste - Marie | |
| Pontoise, France, 95301 | |
| Hopital Claude Gallien | |
| Quincy Sous Senart, France, 91480 | |
| Polyclinique De Courlancy | |
| Reims, France, F-51100 | |
| Clinique Saint Vincent | |
| Saint Gregoire, France, 35700 | |
| Centre du Rouget | |
| Sarcelles, France, 95250 | |
| C.H. Senlis | |
| Senlis, France, 60309 | |
| Centre Medico-Chirurgical Foch | |
| Suresnes, France, 92151 | |
| Clinique Pasteur | |
| Toulouse, France, 31076 | |
| Luxembourg | |
| Hopital de la Ville D'Esch-sur-Alzette | |
| Esch-sur-Alzette, Luxembourg, L-4005 | |
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
| Study Chair: | Jacques Balosso, MD, PhD | CHU de Grenoble - Hopital de la Tronche |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00010062 History of Changes |
| Other Study ID Numbers: | CDR0000068438, FRE-GERCOR-D98-1, EU-20022 |
| Study First Received: | February 2, 2001 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Fluorouracil |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013