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Spots Global Cancer Trial Database for A Trial on SBRT Versus MWA for Inoperable Colorectal Liver Metastases (CLM)

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Trial Identification

Brief Title: A Trial on SBRT Versus MWA for Inoperable Colorectal Liver Metastases (CLM)

Official Title: A Randomized Phase III Trial on Stereotactic Body Radiation Therapy (SBRT) Versus Microwave Ablation (MWA) for Inoperable Colorectal Liver Metastases (CLM)

Study ID: NCT02820194

Study Description

Brief Summary: The trial is designed to perform a rigorous evaluation of efficacy and tolerability of SBRT by means of a randomised, controlled trial in patients affected by inoperable colorectal liver metastases. The chosen comparator is MWA. The two modality treatments (SBRT versus MWA) will be evaluated for short- and longer-term outcomes.

Detailed Description: The trial is a monocentric prospective, randomised controlled, unblinded, parallel-group superiority trial of Stereotactic Body Radiation Therapy (SBRT) versus Microwave Ablation (MWA) for the curative treatment of inoperable colorectal liver metastases. Patients will be randomised on an equal basis to either SBRT or MWA. The two modality treatments (SBRT versus MWA) will be evaluated for short- and longer-term outcomes. The key short-term outcomes will include assessment of local response rate and acute toxicity. Longer-term outcomes will concentrate on oncological aspects of the disease with analysis of disease-free and overall survival and local recurrence rates at 3-year follow-up.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Humanitas Research Hospital, Rozzano, Milan, Italy

Contact Details

Name: Marta Scorsetti, MD

Affiliation: Humanitas Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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