NCT01051284

A Study of Gemcitabine and Cyberknife Radiation Therapy for Pancreatic Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
RADIATION	Cyberknife radiation and gemcitabine	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

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-02-01
• Completion: 2012-03-01
• First posted: 2010-01-18
• Last updated: 2012-04-24

Locations

1 site across 1 country: United States