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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00010062

Enrollment

Unknown

Registered

2003-01-27

Start date

2000-10-31

Completion date

Unknown

Last updated

2009-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

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

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.

Interventions

DRUGfluorouracil

RADIATIONradiation therapy

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion 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

Countries

France, Luxembourg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026