Non-interventional Observational Study of Helical Tomotherapy for Oligometastatic Colorectal Cancer (tomoligo)
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|ClinicalTrials.gov Identifier: NCT00807313|
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : April 30, 2013
Patients with oligometastatic colorectal cancer (5 metastases or less) receive a combination of systemic treatment and often local treatment, such as surgery, radiofrequency ablation and more recently stereotactic body radiotherapy. The aim of this study is to register the results and side effects of stereotactic body radiotherapy (SBRT) by means of helical tomotherapy in the treatment of oligometastatic colorectal cancer.
The trial has two cohorts. Patients in cohort I get consolidation SBRT after best response on first line chemotherapy. Patients in cohort II get SBRT when there is progression under, or no indication for (further) chemotherapy. The primary endpoint is to evaluate the metabolic complete remission rate three months after the start of radiotherapy.
|Condition or disease|
|Colon Cancer Rectal Cancer Colorectal Cancer|
|Study Type :||Observational|
|Actual Enrollment :||53 participants|
|Official Title:||Non-interventional Observational Study of Helical Tomotherapy for Oligometastatic Colorectal Cancer|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
At best response
Patients with oligometastatic colorectal cancer, who presents at best response under chemotherapy, will receive stereotactic body radiotherapy on their residual disease
No indication for chemotherapy
Patients with oligometastatic colorectal cancer, who are progressive under chemotherapy or who are no candidates for (further) chemotherapy, will receive stereotactic body radiotherapy on the sites of disease.
- Metabolic complete remission rate [ Time Frame: Three months ]
- Acute toxicity [ Time Frame: Three months ]
- Progression free survival [ Time Frame: Three to thirty six months ]
- Local control [ Time Frame: Three to thirty six months ]
- Survival [ Time Frame: Three to thirty six months ]
- Late toxicity [ Time Frame: Three to thirty six months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807313
|UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie|
|Brussels, Belgium, 1090|
|Principal Investigator:||Mark De Ridder, MD, PhD||UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie|