Phase I/II Study to Investigate the Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Yes
Marie-Pierre Campeau, MD
Principal Investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Canada: Ethics Review Committee
CE 09.153
NCT01304160
September 2010
July 2013
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