Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
|Pancreatic Cancer Unresectable Pancreatic Cancer||Radiation: stereotactic body radiotherapy||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase I/II Study to Investigate the Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer|
- Number of participants with adverse events [ Time Frame: one year ]Acute and chronic toxicities will be evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0
- Quality of life [ Time Frame: 3 monthly ]Quality of life will be evaluated with the EORTC QLQ-C30 questionnaire
- Local control [ Time Frame: 3 monthly ]Local control will be assessed with 3 monthly CT-scans of the abdomen. RECIST criteria will be used to evaluate local control.
- overall survival [ Time Frame: one and two year ]
|Study Start Date:||September 2010|
|Study Completion Date:||July 2016|
|Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: strereotactic radiotherapy, gemcitabine
stereotactic radiotherapy (30Gray in 5 fractions) followed by gemcitabine
Radiation: stereotactic body radiotherapy
30Gray in 5 fractions
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01304160
|Centre Hospitalier de l'Université de Montréal (CHUM)|
|Montréal, Quebec, Canada, H2L 4M1|
|Principal Investigator:||Marie-Pierre Campeau, MD||Centre hospitalier de l'Université de Montréal (CHUM)|