Proton Therapy for Unresectable Cancer (CA) of Pancreas

University of Florida13 enrolled

Overview

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.

Chemotherapy:Capecitabine on radiation days Proton radiation over 7 weeks Consolidation Chemotherapy:Gemcitabine

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

Proton radiation and chemotherapyRADIATION

Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks . Chemotherapy: Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F) Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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

Collect and Analyze Tumor Control Measures

Time frame: 1 year following the completion of radiation therapy

Data from ClinicalTrials.gov

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