Proton Radiation for Resectable Carcinoma of the 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 combined with chemotherapy and surgery has on you and your pancreatic cancer. This study will look at the side effects from the treatment and the quality of your life in relation to pain. It will also look at how the tumor responds to the combination of treatment with radiation, chemotherapy and surgery.

Detailed Description
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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

Official Title
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A Pilot Study Using Neoadjuvant Proton Beam Radiation Therapy and Chemotherapy for Marginally Resectable 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 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

Ages Eligible for Study
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Minimum Age: 18 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>Proton radiation Capecitabine chemotherapy on radiation days Surgery Gemcitabine chemotherapy | Radiation: Proton radiation and chemotherapy<br>* Neoadjuvant Chemotherapy Capecitabine (Xeloda®) 1,000 mg by mouth twice a day 5 days/week (M-F) on radiation days only Proton radiation 50.4 cobalt gray equivalent(CGE) in 28 fractions over 6 weeks Surgery: Gross total resection of primary tumor and regional lymph nodes done 6 weeks after completion of radiation Adjuvant Chemotherapy starting 2-8 weeks after surgery Suggested Regimen: Gemcitabine (Gemzar®) 1,000 mg/m2 IV total of 18 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 grade 3+ bowel perforation, grade 3+ bleeding and grade 4+ nonhematologic acute adverse events (occuring 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 outcomes |  | 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, Proton radiation, Chemotherapy, Xeloda, Gemzar, Resectable, Surgery