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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
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
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
To demonstrate that radiation treatments can be reproduced as determined by evaluation of the prescription isodose curves
Time frame: 10 days
Acute and late toxicity as determined by patient self-reporting instruments that assess gastrointestinal side effects
Time frame: 6 months
Quality of life as determined by patient self-reporting instruments
Time frame: 6 months
Acute stomach/duodenal mucosa injury as assessed by upper endoscopy
Time frame: one month
Late stomach/duodenal mucosa injury as assessed by upper endoscopy
Time frame: 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
Time frame: 6 months
The feasibility of measuring pancreatic cancer stem cell populations by analysis of fine needle aspirate specimens
Time frame: 6 months
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