Proton Therapy for Unresectable Cancer (CA) of Pancreas

Study Overview
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Brief Summary
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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
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Chemotherapy:Capecitabine on radiation days Proton radiation over 7 weeks Consolidation Chemotherapy:Gemcitabine

Official Title
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A Study Using Photon/Proton Beam Radiation Therapy and Chemotherapy for Unresectable Carcinoma of the Pancreas

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Radiation: Proton radiation and chemotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proton radiation and chemotherapy<br>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. | Radiation: Proton radiation and chemotherapy<br>* 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<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect and Analyze Tumor Control Measures |  | 1 year following the completion of radiation therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic cancer, Unresectable, Proton radiation, Chemotherapy