Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of stereotactic radiation therapy given in five fractions (30 Gray in 5 fractions) followed by gemcitabine in patients with locally advanced pancreatic cancer.

Detailed Description
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The purpose of this phase I/II study is to evaluate the efficacy and toxicity of a different stereotactic body radiation therapy regimen combined with gemcitabine. In the present study, 5 daily fractions of 6 Gray will be given over two weeks. Stereotactic body radiation therapy will be given with the Cyberknife system. This treatment technique allows to give a higher dose to the tumor as compared to conventional external beam radiation while lowering the dose to the normal tissues around. This treatment system is also capable of following the motion that the pancreas assumes during respiration as well as during treatment. This enables us to reduce the margin of security and further reduce dose to surrounding normal tissue. The primary objective of this study is to evaluate acute and chronic toxicity of this regimen of stereotactic radiation therapy followed by gemcitabine. Quality of life, local control and overall survival will also be evaluated.

Official Title
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Phase I/II Study to Investigate the Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer

Conditions
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Pancreatic Cancer, Unresectable Pancreatic Cancer

Intervention / Treatment
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* Radiation: stereotactic body radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pancreatic Adenocarcinoma, histologically and/or cytologically proven Locally advanced pancreatic cancer, surgically non resectable No distant metastasis Work-up including medical history, physical exam, biochemistry, chest X-ray, CT-scan of abdomen and pelvis ECOG performance status : ≤ 2 Primary tumor visible on CT-scan Maximum tumor diameter of 6 cm (including primary tumor and regional lymph nodes) White blood cell count > 3000 /uL, Neutrophils > 1500 /uL, Platelets > 100 000/uL, Hemoglobin > 95 mg/L, Total bilirubin < 1,5 normal limit, AST/ALT < 2,5 normal limit, normal creatinin ≥ 18 years of age Signed informed consent Exclusion Criteria: Prior abdominal radiation therapy Connective tissue disease (scleroderma, lupus) Prior treatment for pancreatic cancer such as radiation therapy, chemotherapy or surgery.

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: strereotactic radiotherapy, gemcitabine<br>stereotactic radiotherapy (30Gray in 5 fractions) followed by gemcitabine | Radiation: stereotactic body radiotherapy<br>* 30Gray in 5 fractions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | Acute and chronic toxicities will be evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0 | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life will be evaluated with the EORTC QLQ-C30 questionnaire | 3 monthly | 
| Local control | Local control will be assessed with 3 monthly CT-scans of the abdomen. RECIST criteria will be used to evaluate local control. | 3 monthly | 
| overall survival |  | one and two year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic cancer, stereotactic body radiotherapy, radiation, gemcitabine, locally advanced