Stereotactic Body Radiation Therapy (SBRT) in Liver Metastasis (COLD 3)
This study is designed to see whether stereotactic body radiation therapy (SBRT) can reduce tumour size, slow progression of the disease, prolong life and improve quality of life. SBRT is concentrated focused radiation therapy delivered very precisely to the liver tumour.
Presently, the treatment for unresectable liver metastases from colorectal cancer is most often chemotherapy or novel targeted therapy. These treatments may improve survival, but not control the metastases permanently; so new treatments are needed to control metastases. It is hoped that knowledge obtained from this study will improve our ability to treat patients with liver tumours that cannot be treated with surgery and other methods, and that SBRT may prove to be a treatment that can lead to long-term and permanent control of liver tumours for some patients.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Stereotactic Body Radiation Therapy for Unresectable Liver Metastases From Colorectal Carcinoma|
- Determine one year local progression free rate, defined as lack of progression within the irradiated volume, using RECIST criteria. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Overall progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- CTC3.0 toxicity [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Cytokine response to radiation and association with complications [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
|Experimental: SBRT for liver mets from colorectal cancer||
Radiation: Stereotactic Body Radiation
Radiation therapy will be delivered on six occasions, over two weeks. Each treatment will take approximately 30 minutes to deliver (up to an hour including all imaging and set-up procedures). You may be asked to swallow 250 cc of oral contrast before each radiation therapy treatment. Pepto Bismol (a liquid that coats the stomach and is used to treat heartburn) and/or water may be combined with the contrast to improve the quality of the stomach's image.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914615
|University Health Network, Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Laura Dawson, MD||University Health Network, Princess Margaret Hospital|