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
Sponsor:
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
  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
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014