Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatment proton radiation and chemotherapy
Phase phase 2
Sponsor University of Florida
Start date March 2008
End date October 2013
Trial size 13 participants
Trial identifier NCT00685763, UFPTI 0609-PC01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
proton radiation and chemotherapy Capecitabine
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

Primary Outcomes

Measure
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

Measure
Collect and Analyze Tumor Control Measures
time frame: 1 year following the completion of radiation therapy

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Study Using Photon/Proton Beam Radiation Therapy and Chemotherapy for Unresectable Carcinoma of the Pancreas
Principal investigator R. Charles Nichols, MD
Description Chemotherapy:Capecitabine on radiation days Proton radiation over 7 weeks Consolidation Chemotherapy:Gemcitabine
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by University of Florida.