Proton Therapy for Unresectable Cancer (CA) of Pancreas (PC01)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study Using Photon/Proton Beam Radiation Therapy and Chemotherapy for Unresectable Carcinoma of the Pancreas|
- 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 ] [ Designated as safety issue: Yes ]
- Collect and Analyze Tumor Control Measures [ Time Frame: 1 year following the completion of radiation therapy ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Estimated Study Completion Date:||December 2020|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: 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.
Other: Proton radiation and chemotherapy
Chemotherapy Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F)
Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .
Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses
Chemotherapy:Capecitabine on radiation days
Proton radiation over 7 weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685763
|United States, Florida|
|University of Florida Proton Therapy Institute|
|Jacksonville, Florida, United States, 32206|
|Principal Investigator:||R. Charles Nichols, MD||University of Florida Proton Therapy Institute|