A Study of Gemcitabine and Cyberknife Radiation Therapy for Pancreatic Cancer

Study Overview
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Brief Summary
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People with pancreatic cancer that cannot be cured by surgery are being asked to participate in this study. The purpose of this study is to test the ability of the radiation oncologists to administer Cyberknife therapy along with Gemcitabine chemotherapy for patients with pancreatic cancer. Radiation and Gemcitabine are both effective at killing cancer cells but they generally cannot be given at the same time. Cyberknife therapy is highly focused radiation that is being used extensively at Georgetown University and around the United States to treat a number of cancers. It is believed that because Cyberknife is so highly focused it can be given safely with regular doses of chemotherapy to attack cancer cells in two ways at the same time. This research is being done because it is not known if using Cyberknife with chemotherapy will be a safe way to treat pancreatic cancer.

Detailed Description
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This is a single arm, open-label pilot study of Cyberknife plus Gemcitabine in 10 patients with locally advanced pancreatic cancer who have not received prior local or systemic therapy for their pancreatic cancer.

Official Title
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A Pilot Study of Full Dose Gemcitabine and Hypofractionated Stereotactic Radiosurgery in the Treatment of Unresectable Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Radiation: Cyberknife radiation and gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven unresectable, non-metastatic pancreatic adenocarcinoma with measurable or evaluable disease and without involvement of the duodenum Performance Status 0-2 No prior anticancer therapy for pancreatic adenocarcinoma No prior anticancer therapy of any kind within the last 5 years Adequate hepatic, bone marrow, and renal function Life expectance of > 12 weeks Women of childbearing potential must have a negative serum pregnancy test Exclusion Criteria: Duodenal involvement of pancreatic cancer Metastatic cancer Active severe infection, or known chronic infection with HIV, hepatitis B virus, or hepatitis C virus Cardiovascular disease including unstable angina, therapy for life-threatening ventricular arrhythmia, myocardial infarction, stroke, or congestive heart failure within the last 6 months Life-threatening visceral disease or other severe concurrent disease Pregnant or breastfeeding Anticipated patient survival under 3 months Another active malignancy within the past 5 years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyberknofe and Gemcitabine<br>Cyberknife radiation and 6 cycles Gemcitabine | Radiation: Cyberknife radiation and gemcitabine<br>* 25 Gray of radiation will be given in 5 fractions using the Cyberknife Gemcitabine 1000 mg/m2 intravenously will be given once a week on days 1, 8, and 15 of every 28-day cycle for 6 cycles<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate that radiation treatments can be reproduced as determined by evaluation of the prescription isodose curves |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute and late toxicity as determined by patient self-reporting instruments that assess gastrointestinal side effects |  | 6 months | 
| Quality of life as determined by patient self-reporting instruments |  | 6 months | 
| Acute stomach/duodenal mucosa injury as assessed by upper endoscopy |  | one month | 
| Late stomach/duodenal mucosa injury as assessed by upper endoscopy |  | 6 months | 
| Feasibility of integrating metabolomic analysis into the evaluation of patients with unresectable pancreatic cancer undergoing chemotherapy and radiation therapy measured by the ability to collect tumor specimens |  | 6 months | 
| The feasibility of measuring pancreatic cancer stem cell populations by analysis of fine needle aspirate specimens |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreas, Newly diagnosed, Cyberknife, Gemcitabine