Proton Radiotherapy for Upper Gastrointestinal Malignancies

Study Overview
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Brief Summary
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The primary objectives are to determine feasibility and the acute toxicity profile of proton therapy with concurrent continuous infusion 5-FU chemotherapy. Secondary objectives are to determine late toxicities and to generate preliminary data on clinical efficacy.

Detailed Description
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This protocol invites patients with cancer of the upper digestive tract who will receive simultaneous proton radiation therapy and chemotherapy. The purpose of this study is to use a newer form of radiation therapy called proton radiation and to determine if its use is safe and effective in people with this type of cancer. Doctors will assess the safety of this method of treatment, record the side effects participants experience while receiving the standard dose of proton radiation.

Official Title
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A Feasibility and Registration Study of Proton Radiotherapy for Upper Gastrointestinal Malignancies

Conditions
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Gastrointestinal Cancer

Intervention / Treatment
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* Radiation: Proton therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologic diagnosis of adenocarcinoma of the upper gastrointestinal tract, including patients with any of the following diagnoses and settings who are candidates to receive radiation which concurrent continuous infusion 5-FU chemotherapy: Pancreatic adenocarcinoma (unresected and adjuvant), Duodenal adenocarcinoma (unresected or adjuvant), Cholangiocarcinoma (unresected or adjuvant), Gastric adenocarcinoma (unresected or adjuvant), Gastroesophageal junction adeno carcinoma (adjuvant) Patient must be >18 years of age. Patient must have an ECOG Performance Status of 0-2, and a life expectancy of greater than or equal to 3 months. Patient must be able to provide informed consent. Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause must be clinically documented. Exclusion Criteria: Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma) Pregnant women, women planning to become pregnant and women that are nursing. Patients who experience surgical complications which prevent radiation from starting for 3 months or more.

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 RT<br>Subjects receive proton radiation | Radiation: Proton therapy<br>* The goal of radiation therapy is to deposit the majority of the radiation dose to the target while minimizing the dose to the surrounding normal tissues.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events | Serious Adverse Events preventing more than 25% of planned treatments using proton radiotherapy. | 90 days | 
| Acute Toxicity | Measured by experience of adverse events | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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upper GI malignancies, concurrent chemoradiation with continuous infusion 5-Fluorouracil chemotherapy