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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00807313

Acronym

tomoligo

Enrollment

Registered

2008-12-11

Start date

2008-12-31

Completion date

2020-11-30

Last updated

2020-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer, Colorectal Cancer, Rectal Cancer

Keywords

Oligometastatic disease, Colorectal cancer, Stereotactic body radiotherapy, Tomotherapy, Metabolic response, Stage IV

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Metabolic complete remission rate	Three months

Secondary

Measure	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

Countries

Belgium

Outcome results