Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer

Phase 2

Completed

• Conditions: Pancreatic Cancer

• Registration Number: NCT00002689
• Lead Sponsor: Center for Molecular Medicine

Brief 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.

Study Timeline

• Study Start: 1995-09
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2007-06
• Study Completion: 2007-06
• Last Update Submitted: 2013-07-17
• Last Update Posted: 2013-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate
Duration of remission
Survival

Secondary Outcome Measures

Name	Time	Method
Patterns of failure

Trial Locations

Locations (2)

Northside Hospital Cancer Center; 🇺🇸 Atlanta, Georgia, United States

Center for Molecular Medicine; 🇺🇸 Garden City, New York, United States