Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00010062|
Recruitment Status : Unknown
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : February 9, 2009
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 or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: fluorouracil Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00010062
|Clinique De Savoie|
|Annemasse, France, 74100|
|Bagnolet, France, 28630|
|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|
|Chartres, France, 28018|
|Clichy, France, 92118|
|Hopital Louis Mourier|
|Dijon, France, 21000|
|Clinique Claude Bernard|
|Ermont, France, 95120|
|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|
|Paris, France, 75007|
|Hopital Saint Antoine|
|Paris, France, 75571|
|Paris, France, 75651|
|Paris, France, 75970|
|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|
|Senlis, France, 60309|
|Centre Medico-Chirurgical Foch|
|Suresnes, France, 92151|
|Toulouse, France, 31076|
|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|