Phase I Study of Stereotactic Body Radiation Therapy and FOLFIRINOX in the Neoadjuvant Therapy of Pancreatic Cancer
Completed · Phase 1
Conditions studied: Cancer of Pancreas, Cancer of the Pancreas, Neoplasms, Pancreatic, Pancreas Cancer, Pancreas Neoplasms
In brief
The purpose of this study is to determine whether using FOLFIRINOX chemotherapy and Stereotactic Body Radiation Therapy (SBRT) prior to surgery in patients with pancreatic cancer is safe and well tolerated. This study will obtain preliminary data on the response of the cancer to this therapy by Magnetic Resonance Imaging (MRI) and by studying the cancer after it is resected surgically. In addition, the investigators will perform biochemical studies on the tumor tissue obtained from your tissue biopsy as well as from the tumor removed by the surgeon in order to measure the effect of treatment with FOLFIRINOX and SBRT on several proteins that may be important in the behavior of pancreatic cancer cells. The data obtained from this trial will be extremely valuable to help improve the approach to treating pancreatic cancer in the future. If you do not undergo surgery after completion of FOLFIRINOX + SBRT, the investigators will request a second biopsy of the tumor under computer tomography (CT) -guidance in order to measure the effect of treatment on your tumor.
Key facts
- Study ID
- NCT01446458
- Run by
- Emory University
- People needed
- 13
- Starts
- 2011-11-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2016-03-22
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Emory University Hospital Midtown — Atlanta, Georgia, United States
- Emory University Winship Cancer Institute — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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