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

Colorectal Cancer Clinical Trial

— tomoligo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807313
• Other study ID #: RCT501
• Status: Completed
• Start date: December 2008
• Est. completion date: November 30, 2020

Study information

• Verified date: December 2020
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: November 30, 2020
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Rectal Cancer

Locations

Country	Name	City	State
Belgium	UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Verellen D, De Ridder M, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic complete remission rate		Three months
Secondary	Acute toxicity		Three months
Secondary	Progression free survival		Three to thirty six months
Secondary	Local control		Three to thirty six months
Secondary	Survival		Three to thirty six months
Secondary	Late toxicity		Three to thirty six months