Study of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer

Study Overview
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Brief Summary
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This purpose of this study is to determine the highest tolerated dose of Stereotactic Body Radiation Therapy (SBRT) and also to determine the appropriate dose for intact pancreatic cancer.

Official Title
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A Study of Stereotactic Body Radiation Therapy in Patients With Unresected Carcinoma of the Pancreas or Ampulla

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Radiation: Stereotactic Radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have histologically confirmed, unresected cancer of the pancreas or ampulla. The cancer may include any invasive histology (e.g. adenocarcinoma, neuroendocrine carcinoma). Patients must have measurable radiographic disease.Patients with previous complete resection are only eligible if there is measurable radiographic disease which is clearly felt to represent locally recurrent disease. Patients may receive any number of cycles of chemotherapy prior to treatment with SBRT, but not within 2 weeks of the first fraction of RT. Age > or = 18 years. Eastern Cooperative Oncology Group (ECOG) performance status < or = 2 (Karnofsky > or = 60%) Life expectancy of greater than 3 months. Patients must have normal organ and marrow function. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Concurrent investigational therapy delivered over the period of treatment or observation (28 days post-RT) for dose limiting toxicity. Prior radiation therapy to the abdominal area which would overlap with the proposed area of treatment. Pregnancy. Primary disease > 7.5 cm in largest diameter as measured by CT or MRI. Gross extension of tumor into the lumen of the duodenum. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Use of bevacizumab or vascular endothelial growth factor inhibitor chemotherapy within 3 months before RT or 6 months after RT.

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: Stereotactic Radiation<br>Escalating doses of SBRT in three doses over ten days. | Radiation: Stereotactic Radiation<br>* Escalating Doses of SBRT in periods of three doses over 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose (phase 1) | Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation. | 28 days | 
| Identify the appropriate dose for treatment of unresected carcinoma of the ampulla or pancreas |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reported side effects |  | 12 months after treatment | 
| Change in patient reported pain score using visual analog scale | Using the visual analog scale, patients rate pain from 1-10 with higher scores indicate greater pain intensity. | 12 months after treatment | 
| Number of patients eligible for surgery to remove tumor after treatment |  | 12 months after treatment | 
| Number of patients with disease control | Number of patients with no disease progression as measured by tumor imaging | 12 months after treatment | 
| Change in patient reported outcomes using FACT-Hepatobiliary (FACT-Hep) quality of life questionnaire. |  | 12 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Cancer, Stereotactic Radiation