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Completed

NCT Number: NCT00807313

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

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie

Brussels, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Metabolic complete remission rate

    Time frame: Three months

Secondary outcomes

  1. Acute toxicity

    Time frame: Three months

  2. Progression free survival

    Time frame: Three to thirty six months

  3. Local control

    Time frame: Three to thirty six months

  4. Survival

    Time frame: Three to thirty six months

  5. Late toxicity

    Time frame: Three to thirty six months

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Acronym: tomoligo

Important dates

Study start
2008
Primary completion
2011
Study completion
2020
First posted
Dec 11, 2008
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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