A Study Using Photon/Proton Beam Radiation Therapy and Chemotherapy for Unresectable Carcinoma of the Pancreas
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
A Study Using Photon/Proton Beam Radiation Therapy and Chemotherapy for Unresectable Carcinoma of the Pancreas
Chemotherapy:Capecitabine on radiation days
Proton radiation over 7 weeks
Consolidation Chemotherapy:Gemcitabine
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.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Cumulative incidence of grade3+ bowel perforation, grade 3+ bleeding and grade4+ nonhematologic acute adverse events (occuring within 90 days of treatment start)
Outcome Time Frame:
1 year following the completion of radiation therapy
Safety Issue:
Yes
Principal Investigator
R. Charles Nichols, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Florida Proton Therapy Institute
Authority:
United States: Institutional Review Board
Study ID:
UFPTI 0609-PC01
NCT ID:
NCT00685763
Start Date:
March 2008
Completion Date:
July 2038
Related Keywords:
- Pancreatic Cancer
- Pancreatic cancer
- Unresectable
- Proton radiation
- Chemotherapy
- Pancreatic Neoplasms
Name | Location |
|---|---|
| University of Florida Proton Therapy Institute | Jacksonville, Florida 32206 |
