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

NCT00010062 | Unknown Phase 2

• 3 other identifiers: CDR0000068438FRE-GERCOR-D98-1EU-20022
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 30

Brief 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.

Conditions

Pancreatic Cancer

Keywords

stage I pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer; adenocarcinoma of the pancreas; stage IV pancreatic cancer

Interventions

fluorouracil DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (30)

Clinique De Savoie

Annemasse, 74100, France

Location

Clinique Floreal

Bagnolet, 28630, France

Location

Clinique Tivoli

Bordeaux, F-33030, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Clinique Saint - Jean

Cagne-sur-Mer, 06800, France

Location

Polyclinique Saint Jean

Cagnes-sur-Mer, France

Location

Hopital Fontenoy

Chartres, 28018, France

Location

Hopital Beaujon

Clichy, 92118, France

Location

Hopital Louis Mourier

Colombes, France

Location

Hopital Drevon

Dijon, 21000, France

Location

Clinique Claude Bernard

Ermont, 95120, France

Location

Clinique Pasteur

Évreux, 27000, France

Location

Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie

Gien, 45500, France

Location

CHR de Grenoble - La Tronche

Grenoble, F-38043, France

Location

Hopital Saint - Louis

La Rochelle, 17000, France

Location

Centre Jean Bernard

Le Mans, 72000, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Hopital Laennec

Paris, 75007, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Hopital Tenon

Paris, 75970, France

Location

Clinique Ste - Marie

Pontoise, 95301, France

Location

Hopital Claude Gallien

Quincy-sous-Sénart, 91480, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

Clinique Saint Vincent

Saint-Grégoire, 35700, France

Location

Centre du Rouget

Sarcelles, 95250, France

Location

C.H. Senlis

Senlis, 60309, France

Location

Centre Medico-Chirurgical Foch

Suresnes, 92151, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Hopital de la Ville D'Esch-sur-Alzette

Esch-sur-Alzette, L-4005, Luxembourg

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Fluorouracil; Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Jacques Balosso, MD, PhD

  CHU de Grenoble - Hopital de la Tronche

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 2, 2001
• First Posted: January 27, 2003
• Study Start: October 1, 2000
• Last Updated: February 9, 2009

Record last verified: 2007-04

Locations

LU (1); FR (29)