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

Universitair Ziekenhuis Brussel

Status: Completed

Conditions: Colon Cancer; Colorectal Cancer; Rectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT00807313

RCT501

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

53 participants in 2 patient groups

At best response

Description:

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

Description:

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.