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

Primary Purpose

Pancreatic Cancer

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
fluorouracil
radiation therapy
Sponsored by
GERCOR - Multidisciplinary Oncology Cooperative Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique De Savoie
  • Clinique Floreal
  • Clinique Tivoli
  • Centre Regional Francois Baclesse
  • Clinique Saint - Jean
  • Polyclinique Saint Jean
  • Hopital Fontenoy
  • Hopital Beaujon
  • Hopital Louis Mourier
  • Hopital Drevon
  • Clinique Claude Bernard
  • Clinique Pasteur
  • Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie
  • CHR de Grenoble - La Tronche
  • Hopital Saint - Louis
  • Centre Jean Bernard
  • Centre Hospital Regional Universitaire de Limoges
  • Hopital Laennec
  • Hopital Saint Antoine
  • CHU Pitie-Salpetriere
  • Hopital Tenon
  • Clinique Ste - Marie
  • Hopital Claude Gallien
  • Polyclinique De Courlancy
  • Clinique Saint Vincent
  • Centre du Rouget
  • C.H. Senlis
  • Centre Medico-Chirurgical Foch
  • Clinique Pasteur
  • Hopital de la Ville D'Esch-sur-Alzette

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
February 6, 2009
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT00010062
Brief Title
Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer
Official Title
Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Balosso, MD, PhD
Organizational Affiliation
CHU de Grenoble - Hopital de la Tronche
Official's Role
Study Chair
Facility Information:
Facility Name
Clinique De Savoie
City
Annemasse
ZIP/Postal Code
74100
Country
France
Facility Name
Clinique Floreal
City
Bagnolet
ZIP/Postal Code
28630
Country
France
Facility Name
Clinique Tivoli
City
Bordeaux
ZIP/Postal Code
F-33030
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Clinique Saint - Jean
City
Cagne-sur-Mer
ZIP/Postal Code
06800
Country
France
Facility Name
Polyclinique Saint Jean
City
Cagnes Sur Mer
Country
France
Facility Name
Hopital Fontenoy
City
Chartres
ZIP/Postal Code
28018
Country
France
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92118
Country
France
Facility Name
Hopital Louis Mourier
City
Colombes
Country
France
Facility Name
Hopital Drevon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Clinique Claude Bernard
City
Ermont
ZIP/Postal Code
95120
Country
France
Facility Name
Clinique Pasteur
City
Evreux
ZIP/Postal Code
27000
Country
France
Facility Name
Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie
City
Gien
ZIP/Postal Code
45500
Country
France
Facility Name
CHR de Grenoble - La Tronche
City
Grenoble
ZIP/Postal Code
F-38043
Country
France
Facility Name
Hopital Saint - Louis
City
La Rochelle
ZIP/Postal Code
17000
Country
France
Facility Name
Centre Jean Bernard
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Centre Hospital Regional Universitaire de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital Laennec
City
Paris
ZIP/Postal Code
75007
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
CHU Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Clinique Ste - Marie
City
Pontoise
ZIP/Postal Code
95301
Country
France
Facility Name
Hopital Claude Gallien
City
Quincy Sous Senart
ZIP/Postal Code
91480
Country
France
Facility Name
Polyclinique De Courlancy
City
Reims
ZIP/Postal Code
F-51100
Country
France
Facility Name
Clinique Saint Vincent
City
Saint Gregoire
ZIP/Postal Code
35700
Country
France
Facility Name
Centre du Rouget
City
Sarcelles
ZIP/Postal Code
95250
Country
France
Facility Name
C.H. Senlis
City
Senlis
ZIP/Postal Code
60309
Country
France
Facility Name
Centre Medico-Chirurgical Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Hopital de la Ville D'Esch-sur-Alzette
City
Esch-sur-Alzette
ZIP/Postal Code
L-4005
Country
Luxembourg

12. IPD Sharing Statement

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

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