Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy combined with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of brachytherapy followed by external-beam radiation therapy plus chemotherapy in treating patients who have pancreatic cancer that cannot be removed surgically.
Radiation: phosphorus P32
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Interstitial Colloidal 32P Integrated in The Treatment of Non-Resectable Pancreatic Cancer|
- Response rate [ Designated as safety issue: No ]
- Duration of remission [ Designated as safety issue: No ]
- Survival [ Designated as safety issue: No ]
- Patterns of failure [ Designated as safety issue: No ]
|Study Start Date:||September 1995|
|Study Completion Date:||June 2007|
- Determine the response/remission rate, survival, and degree of local control from interstitial colloidal phosphorus P32 followed by external beam radiotherapy and chemotherapy in patients with unresectable pancreatic cancer.
OUTLINE: Patients are stratified according to prior therapy (yes vs no).
Patients receive dexamethasone intratumorally, then macroaggregated albumin and interstitial phosphorus P32 intratumorally. Most patients receive a second course of this brachytherapy.
Patients then proceed to chemoradiotherapy beginning 7-14 days after brachytherapy. Radiotherapy is administered 5 days a week for 6.4 weeks. Fluorouracil IV is administered every other day for 4 doses during weeks 1 and 2.
Patients are followed monthly for 1 year then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002689
|United States, Georgia|
|Northside Hospital Cancer Center|
|Atlanta, Georgia, United States, 30342-1611|
|United States, New York|
|Center for Molecular Medicine|
|Garden City, New York, United States, 11530|
|Study Chair:||Stanley E. Order, MD, ScD, FACR||Center for Molecular Medicine|