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Proton Therapy for Unresectable Cancer (CA) of Pancreas

Not Applicable
Completed
Conditions
Pancreatic Cancer
Registration Number
NCT00685763
Lead Sponsor
University of Florida
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
13
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
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)1 year following the completion of radiation therapy
Secondary Outcome Measures
NameTimeMethod
Collect and Analyze Tumor Control Measures1 year following the completion of radiation therapy

Trial Locations

Locations (1)

University of Florida Proton Therapy Institute

🇺🇸

Jacksonville, Florida, United States

University of Florida Proton Therapy Institute
🇺🇸Jacksonville, Florida, United States

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