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

Completed

• Conditions: Colorectal Cancer; Colon Cancer; Rectal Cancer

• Registration Number: NCT00807313
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-10
• Study First Submitted QC: 2008-12-10
• Study First Posted: 2008-12-11
• Primary Completion: 2011-07
• Study Completion: 2020-11-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-28
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolic complete remission rate	Three months

Secondary Outcome Measures

Name	Time	Method
Local control	Three to thirty six months
Acute toxicity	Three months
Progression free survival	Three to thirty six months
Late toxicity	Three to thirty six months
Survival	Three to thirty six months

Trial Locations

Locations (1)

UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie; 🇧🇪 Brussels, Belgium