Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00010062
• Other study ID #: CDR0000068438
• Secondary ID: FRE-GERCOR-D98-1
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 2, 2001
• Last updated: February 6, 2009
• Start date: October 2000

Study information

• Verified date: April 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• fluorouracil

Radiation:
• radiation therapy

Locations

Country	Name	City	State
France	Clinique De Savoie	Annemasse
France	Clinique Floreal	Bagnolet
France	Clinique Tivoli	Bordeaux
France	Centre Regional Francois Baclesse	Caen
France	Clinique Saint - Jean	Cagne-sur-Mer
France	Polyclinique Saint Jean	Cagnes Sur Mer
France	Hopital Fontenoy	Chartres
France	Hopital Beaujon	Clichy
France	Hopital Louis Mourier	Colombes
France	Hopital Drevon	Dijon
France	Clinique Claude Bernard	Ermont
France	Clinique Pasteur	Evreux
France	Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie	Gien
France	CHR de Grenoble - La Tronche	Grenoble
France	Hopital Saint - Louis	La Rochelle
France	Centre Jean Bernard	Le Mans
France	Centre Hospital Regional Universitaire de Limoges	Limoges
France	CHU Pitie-Salpetriere	Paris
France	Hopital Laennec	Paris
France	Hopital Saint Antoine	Paris
France	Hopital Tenon	Paris
France	Clinique Ste - Marie	Pontoise
France	Hopital Claude Gallien	Quincy Sous Senart
France	Polyclinique De Courlancy	Reims
France	Clinique Saint Vincent	Saint Gregoire
France	Centre du Rouget	Sarcelles
France	C.H. Senlis	Senlis
France	Centre Medico-Chirurgical Foch	Suresnes
France	Clinique Pasteur	Toulouse
Luxembourg	Hopital de la Ville D'Esch-sur-Alzette	Esch-sur-Alzette

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Countries where clinical trial is conducted

France,  Luxembourg,