Proton Radiation for Resectable Carcinoma of the Pancreas
Not Applicable
Completed
- Conditions
- Pancreatic Cancer
- Interventions
- Radiation: Proton radiation and chemotherapy
- Registration Number
- NCT00763516
- Lead Sponsor
- University of Florida
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Proton radiation and chemotherapy Proton radiation and chemotherapy Proton radiation Capecitabine chemotherapy on radiation days Surgery Gemcitabine chemotherapy
- Primary Outcome Measures
Name Time Method Cumulative incidence of grade 3+ bowel perforation, grade 3+ bleeding and grade 4+ nonhematologic acute adverse events (occuring within 90 days of treatment start) 1 year following the completion of radiation therapy
- Secondary Outcome Measures
Name Time Method Collect and analyze tumor control outcomes 1 year following the completion of radiation therapy
Trial Locations
- Locations (1)
University of Florida Proton Therapy Institute
🇺🇸Jacksonville, Florida, United States