A Pilot Study Using Neoadjuvant Proton Beam Radiation Therapy and Chemotherapy for Marginally Resectable Carcinoma of the Pancreas
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Cancer
- Sponsor
- University of Florida
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Cumulative incidence of grade 3+ bowel perforation, grade 3+ bleeding and grade 4+ nonhematologic acute adverse events (occuring within 90 days of treatment start)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to find out what effects, good and/or bad, proton radiation combined with chemotherapy and surgery has on you and your pancreatic cancer. This study will look at the side effects from the treatment and the quality of your life in relation to pain. It will also look at how the tumor responds to the combination of treatment with radiation, chemotherapy and surgery.
Detailed Description
Chemotherapy capecitabine on radiation days Proton radiation over 6 weeks Surgery 6 weeks after radiation completion Adjuvant Chemotherapy starting 2-8 weeks after surgery with Gemzar
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pathologically confirmed adenocarcinoma of the pancreas.
- •Patients must have marginally resectable disease.
- •Patients with biliary obstruction must have adequate drainage prior to starting chemoradiation.
Exclusion Criteria
- •Evidence of distant metastasis including peritoneal seeding and/or ascites.
- •Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment.
- •Prior surgical resection.
- •Gastroduodenal obstruction
Outcomes
Primary Outcomes
Cumulative incidence of grade 3+ bowel perforation, grade 3+ bleeding and grade 4+ nonhematologic acute adverse events (occuring within 90 days of treatment start)
Time Frame: 1 year following the completion of radiation therapy
Secondary Outcomes
- Collect and analyze tumor control outcomes(1 year following the completion of radiation therapy)