A Pilot Study Using Neoadjuvant Proton Beam Radiation Therapy and Chemotherapy for Marginally Resectable Carcinoma of the Pancreas
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
A Pilot Study Using Neoadjuvant Proton Beam Radiation Therapy and Chemotherapy for Marginally Resectable Carcinoma of the Pancreas
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Cumulative incidence of grade 3+ bowel perforation, grade 3+ bleeding and grade 4+ 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
Romaine C Nichols, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Florida Proton Therapy Institute
Authority:
United States: Institutional Review Board
Study ID:
UFPTI 0704-PC02
NCT ID:
NCT00763516
Start Date:
February 2009
Completion Date:
September 2040
Related Keywords:
- Pancreatic Cancer
- Pancreatic Cancer
- Proton radiation
- Chemotherapy
- Xeloda
- Gemzar
- Resectable
- Surgery
- Carcinoma
- Pancreatic Neoplasms
Name | Location |
|---|---|
| University of Florida Proton Therapy Institute | Jacksonville, Florida 32206 |
