Postoperative Proton Radiotherapy With Chemo for Pancreatic Cancer

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 has on resected pancreatic cancer.

Detailed Description
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Proton radiation with concomitant chemotherapy

Official Title
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A Phase II Trial of Postoperative Proton Radiotherapy With Concomitant Chemotherapy for Patients With Resected Pancreatic Adenocarcinoma

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Radiation: Proton radiation
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection Post resection CA19-9 tumor marker baseline Exclusion Criteria: - Previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the patient has been disease free for at least 5 years prior to study consent

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1- R(0) negative<br>50.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine | Radiation: Proton radiation<br>* Proton Radiation Therapy: R(0) negative ... 50.40 cobalt gray equivalent (CGE) at 1.8 CGE per fraction ; R(1) micro-positive ...54.00 CGE at 1.8 CGE per fraction; R(2) gross positive...59.40 CGE at 1.8 CGE per fraction<br>Drug: Gemcitabine<br>* Gemcitabine 300 mg/m2 infused over 30 minutes, weekly during proton therapy.<br>* Other names: Gemzar;|
| Experimental: 2- R(1) micro-positive<br>54.00 cobalt gray equivalent(CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine | Radiation: Proton radiation<br>* Proton Radiation Therapy: R(0) negative ... 50.40 cobalt gray equivalent (CGE) at 1.8 CGE per fraction ; R(1) micro-positive ...54.00 CGE at 1.8 CGE per fraction; R(2) gross positive...59.40 CGE at 1.8 CGE per fraction<br>Drug: Gemcitabine<br>* Gemcitabine 300 mg/m2 infused over 30 minutes, weekly during proton therapy.<br>* Other names: Gemzar;|
| Experimental: 3- R(2) gross positive<br>59.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine | Radiation: Proton radiation<br>* Proton Radiation Therapy: R(0) negative ... 50.40 cobalt gray equivalent (CGE) at 1.8 CGE per fraction ; R(1) micro-positive ...54.00 CGE at 1.8 CGE per fraction; R(2) gross positive...59.40 CGE at 1.8 CGE per fraction<br>Drug: Gemcitabine<br>* Gemcitabine 300 mg/m2 infused over 30 minutes, weekly during proton therapy.<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation Toxicity | Assessment of acute/late severe (defined as grade 3-5) radiation toxicity at the completion of therapy. Acute toxicity will be defined to be toxicity occurring within 90 days from the start of radiation treatment, and late toxicity will be defined as toxicity occurring more than 90 days from the start of radiation treatment. | 90 days after completion of RT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Rate | One year overall survival rate | 1 year after completion of RT | 
| Response rate via CA 19-9 |  | Every 3 months for 2 years, then every 6 months for 3-5 years then annually thereafter | 

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