A Study Using Photon/Proton Beam Radiation Therapy and Chemotherapy for Unresectable Carcinoma of the Pancreas
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- 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)
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Proton radiation and chemotherapy
Chemotherapy and Radiation Combination
Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks.
Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.
Consolidation Chemotherapy starting 4 weeks after the completion of radiation
Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.
Intervention: Proton radiation and chemotherapy (Radiation)
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
Secondary Outcomes
- Collect and Analyze Tumor Control Measures(1 year following the completion of radiation therapy)