Non-Interventional Observational Study of Helical Tomotherapy for Oligometastatic Colorectal Cancer - Full Text View

Sponsored by:	Universitair Ziekenhuis Brussel
Information provided by:	Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:	NCT00807313

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

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Non-Interventional Observational Study of Helical Tomotherapy for Oligometastatic Colorectal Cancer

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	81
Study Start Date:	December 2008

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 livercirrhosis
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

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

Contacts

Contact: Mark De Ridder, MD, PhD	+3224776147	mark.deridder@uzbrussel.be
Contact: Harijati Versmessen, MD	+3224763407	harijati.versmessen@uzbrussel.be

Locations

Belgium
UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie	Recruiting
Brussels, Belgium, 1090
Contact: Mark De Ridder, MD, PhD +3224776147 mark.deridder@uzbrussel.be
Contact: Harijati Versmessen, MD +3224773407 harijati.versmessen@uzbrussel.be
Principal Investigator: Mark De Ridder, MD, PhD
Sub-Investigator: Benedikt Engels, MD
Sub-Investigator: Dirk Verellen, MSc, PhD

Sponsors and Collaborators

Universitair Ziekenhuis Brussel

Investigators

Principal Investigator:

Mark De Ridder, MD, PhD

UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie

More Information

Publications:

Verellen D, Ridder MD, Linthout N, Tournel K, Soete G, Storme G. Innovations in image-guided radiotherapy. Nat Rev Cancer. 2007 Dec;7(12):949-60. Review. Erratum in: Nat Rev Cancer. 2008 Jan;8(1):71.

Responsible Party:	UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie ( Prof. Dr. Mark De Ridder )
Study ID Numbers:	RCT501
Study First Received:	December 10, 2008
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00807313
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

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms

Rectal neoplasm
Digestive System Diseases
Gastrointestinal Neoplasms
Colonic Neoplasms
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009