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

December 10, 2008
April 29, 2013
December 2008
July 2011   (final data collection date for primary outcome measure)
Metabolic complete remission rate [ Time Frame: Three months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00807313 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Non-interventional Observational Study of Helical Tomotherapy for Oligometastatic Colorectal Cancer
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with oligometastatic (5 metastases or less) colorectal cancer

  • Colon Cancer
  • Rectal Cancer
  • Colorectal Cancer
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00807313
RCT501
No
Mark De Ridder, Universitair Ziekenhuis Brussel
Universitair Ziekenhuis Brussel
Not Provided
Principal Investigator: Mark De Ridder, MD, PhD UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie
Universitair Ziekenhuis Brussel
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP