Proton Therapy for Unresectable Cancer (CA) of Pancreas

Not Applicable

Completed

• Conditions: Pancreatic Cancer
• Interventions: Radiation: Proton radiation and chemotherapy

• Registration Number: NCT00685763
• Lead Sponsor: University of Florida

Brief 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.

Detailed Description

Chemotherapy:Capecitabine on radiation days

Proton radiation over 7 weeks

Consolidation Chemotherapy:Gemcitabine

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-05-22
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-28
• Primary Completion: 2013-10
• Results First Submitted: 2014-05-23
• Results First Submitted QC: 2014-07-01
• Results First Posted: 2014-07-03
• Study Completion: 2017-06-29
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-21
• Last Update Posted: 2017-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proton radiation and chemotherapy	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.

Primary Outcome Measures

Name	Time	Method
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)	1 year following the completion of radiation therapy

Secondary Outcome Measures

Name	Time	Method
Collect and Analyze Tumor Control Measures	1 year following the completion of radiation therapy

Trial Locations

Locations (1)

University of Florida Proton Therapy Institute; 🇺🇸 Jacksonville, Florida, United States