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Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer
This study is ongoing, but not recruiting participants.
Study NCT00010062   Information provided by National Cancer Institute (NCI)
First Received: February 2, 2001   Last Updated: February 6, 2009   History of Changes

February 2, 2001
February 6, 2009
October 2000
 
 
 
Complete list of historical versions of study NCT00010062 on ClinicalTrials.gov Archive Site
 
 
 
Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer
Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer

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.

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.

Phase II
Interventional
Treatment
Pancreatic Cancer
  • Drug: fluorouracil
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Luxembourg
 
NCT00010062
 
CDR0000068438, FRE-GERCOR-D98-1, EU-20022
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
 
Study Chair: Jacques Balosso, MD, PhD CHU de Grenoble - Hopital de la Tronche
National Cancer Institute (NCI)
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP