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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark De Ridder, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT00807313
First received: December 10, 2008
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

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.


Condition
Colon Cancer
Rectal Cancer
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Observational Study of Helical Tomotherapy for Oligometastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • Metabolic complete remission rate [ Time Frame: Three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute toxicity [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
  • Progression free survival [ Time Frame: Three to thirty six months ] [ Designated as safety issue: No ]
  • Local control [ Time Frame: Three to thirty six months ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: Three to thirty six months ] [ Designated as safety issue: No ]
  • Late toxicity [ Time Frame: Three to thirty six months ] [ Designated as safety issue: Yes ]

Enrollment: 53
Study Start Date: December 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
At best response
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with oligometastatic (5 metastases or less) colorectal cancer

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807313

Locations
Belgium
UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie
Brussels, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
Principal Investigator: Mark De Ridder, MD, PhD UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark De Ridder, Head of Radiotherapy Department, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT00807313     History of Changes
Other Study ID Numbers: RCT501
Study First Received: December 10, 2008
Last Updated: April 29, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitair Ziekenhuis Brussel:
Oligometastatic disease
Colorectal cancer
Stereotactic body radiotherapy
Tomotherapy
Metabolic response
Stage IV

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 22, 2014