Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00002689|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: dexamethasone Drug: fluorouracil Radiation: brachytherapy Radiation: phosphorus P32 Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Official Title:||Phase II Interstitial Colloidal 32P Integrated in The Treatment of Non-Resectable Pancreatic Cancer|
|Study Start Date :||September 1995|
|Actual Study Completion Date :||June 2007|
- Response rate
- Duration of remission
- Patterns of failure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|