NCT00002689

Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer

Phase II Interstitial Colloidal 32P Integrated in The Treatment of Non-Resectable Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Center for Molecular Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	dexamethasone
DRUG	fluorouracil
RADIATION	brachytherapy
RADIATION	phosphorus P32
RADIATION	radiation therapy

Timeline

• Start date: 1995-09-01
• Completion: 2007-06-01
• First posted: 2003-01-27
• Last updated: 2013-07-18

Locations

2 sites across 1 country: United States