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 2015|
|Estimated Primary Completion Date:||August 2015 (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.
From July 2003 to May 2007, over 50 patients with liver metastases participated in two studies at Princess Margaret Hospital (PMH) designed to determine the safety of treating liver metastases with SBRT. These studies have shown that SBRT can be delivered safely to the majority of patients with liver metastases. The treated tumour was controlled (shrank or remained the same size) in 74% of patients at one year following treatment. The median survival of patients was 16 months (i.e.half of patients survived longer and half shorter than 16 months). This survival rate is better than that expected in patients whose tumours grew bigger even though they were treated with chemotherapy. Supportive care only (no treatment other than care to make you feel better) in these patients is associated with a median survival rate of 6-12 months. We expect that the benefits of SBRT in this study will be similar to those observed in our initial studies.
|University Health Network, Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Laura Dawson, MD||University Health Network, Princess Margaret Hospital|