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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Neoadjuvant Chemotherapy Capecitabine (Xeloda®) 1,000 mg by mouth twice a day 5 days/week (M-F) on radiation days only Proton radiation 50.4 cobalt gray equivalent(CGE) in 28 fractions over 6 weeks Surgery: Gross total resection of primary tumor and regional lymph nodes done 6 weeks after completion of radiation Adjuvant Chemotherapy starting 2-8 weeks after surgery Suggested Regimen: Gemcitabine (Gemzar®) 1,000 mg/m2 IV total of 18 doses
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States
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
Collect and analyze tumor control outcomes
Time frame: 1 year following the completion of radiation therapy
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