Trials / Unknown
UnknownNCT00010062
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | fluorouracil | |
| RADIATION | radiation therapy |
Timeline
- Start date
- 2000-10-01
- First posted
- 2003-01-27
- Last updated
- 2009-02-09
Locations
30 sites across 2 countries: France, Luxembourg
Source: ClinicalTrials.gov record NCT00010062. Inclusion in this directory is not an endorsement.