Non-interventional Observational Study of Helical Tomotherapy for Oligometastatic Colorectal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Non-interventional Observational Study of Helical Tomotherapy for Oligometastatic Colorectal Cancer

Conditions
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Colon Cancer, Rectal Cancer, Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with (residual) oligometastatic CRC: ≤ 5 mets Primary tumor treated with curative intention (surgery, radiotherapy, chemoradiotherapy) Functional liver volume > 1000cc if livermets, lung DLCO > 30% if lungmets. No Child B or C liver cirrhosis No contra-indications for radiation of all metastatic CRC (= no violation of constraints of organs at risk (OAR)) No mets from another carcinoma Age > 18 years WHO-PS ≤ 2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| At best response<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic complete remission rate |  | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity |  | Three months | 
| Progression free survival |  | Three to thirty six months | 
| Local control |  | Three to thirty six months | 
| Survival |  | Three to thirty six months | 
| Late toxicity |  | Three to thirty six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oligometastatic disease, Colorectal cancer, Stereotactic body radiotherapy, Tomotherapy, Metabolic response, Stage IV