A Study Using Photon/Proton Beam Radiation Therapy and Chemotherapy for Unresectable Carcinoma of the Pancreas

University of Florida1 site in 1 country13 target enrollmentMarch 2008

ConditionsPancreatic Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pancreatic Cancer
Sponsor: University of Florida
Enrollment: 13
Locations: 1
Primary Endpoint: Cumulative Incidence of grade3+ Bowel Perforation, Grade 3+ Bleeding (Ocurring Withing 1 Years) and grade4+ Nonhematologic Acute Adverse Events (Limited to Within 90 Days of Treatment Start)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to find out what effects, good and/or bad, proton radiation and chemotherapy has on you and your pancreatic cancer.

Detailed Description

Chemotherapy:Capecitabine on radiation days Proton radiation over 7 weeks Consolidation Chemotherapy:Gemcitabine

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

June 29, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Florida

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Pathologically confirmed adenocarcinoma of the pancreas.
•Patients must be medically inoperable or have unresectable disease

Exclusion Criteria

•Evidence of distant metastasis; evidence of metastatic disease in the major viscera (organs), peritoneal seeding and/or ascites.
•Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment.
•Prior surgical resection.

Outcomes

Primary Outcomes

Cumulative Incidence of grade3+ Bowel Perforation, Grade 3+ Bleeding (Ocurring Withing 1 Years) and grade4+ Nonhematologic Acute Adverse Events (Limited to Within 90 Days of Treatment Start)

Time Frame: 1 year following the completion of radiation therapy