A Pilot Study Using Neoadjuvant Proton Beam Radiation Therapy and Chemotherapy for Marginally Resectable Carcinoma of the Pancreas
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- 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)
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Proton radiation and chemotherapy
Proton radiation
Capecitabine chemotherapy on radiation days
Surgery
Gemcitabine chemotherapy
Intervention: Proton radiation and chemotherapy (Radiation)
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)