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ACTIVE NOT RECRUITING
NCT03721341
PHASE3

Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors

Sponsor: David Palma

View on ClinicalTrials.gov

Summary

In patients with a limited oligometastatic burden (cancer has spread but is not yet considered metastatic), emerging evidence suggests that treatment of all sites of disease with ablative therapies can improve patient outcomes, including overall- and progression-free survival. The application of Stereotactic Ablative Radiotherapy (SABR) for patients with 4-10 metastatic deposits appears promising, yet it is unclear if all patients with greater than 3 oligometastatic lesions benefit from ablative therapies in terms of improved Overall Survival (OS), Progression Free Survival (PFS), or quality of life. The purpose of this study is to assess the impact of SABR, compared to standard of care treatment, on overall survival, oncologic outcomes, and quality of life in patients with a controlled primary tumor and 4-10 metastatic lesions.

Official title: A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

204

Start Date

2019-02-22

Completion Date

2029-01

Last Updated

2025-09-18

Healthy Volunteers

No

Interventions

RADIATION

Palliative Radiation

Investigators should follow the principles of palliative radiotherapy as per the individual institution in order to alleviate symptoms or prevent complications. If radiotherapy is indicated, recommended doses are 8 Gy in 1 fraction, 20 Gy in 5 fractions, and 30 Gy in 10 fractions.

DRUG

Chemotherapy

Chemotherapy may be given as indicated.

DRUG

Immunotherapy

Immunotherapy may be given as indicated.

DRUG

Hormones

Hormones may be given as indicated.

OTHER

Observation

Observation only is acceptable if this is the standard practice.

RADIATION

Stereotactic Ablative Radiotherapy

Total dose of radiation and number of fractions will depend on the site of disease. Doses are 20 Gy in 1 fraction, 30 Gy in 3 fractions (every 2 days), or 35 Gy in 5 fractions (daily).

Locations (14)

Alfred Health

Melbourne, Victoria, Australia

BC Cancer Agency, Vancouver Island Centre

Victoria, British Columbia, Canada

Nova Scotia Health Authortiy

Halifax, Nova Scotia, Canada

Health Sciences North

Greater Sudbury, Ontario, Canada

Grand River Hospital

Kitchener, Ontario, Canada

London Regional Cancer Program of the Lawson Health Research Institute

London, Ontario, Canada

Trillium Health Partners-Credit Valley Hospital

Mississauga, Ontario, Canada

Niagra Health System

St. Catharines, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Centre hospitalier de l'Université de Montréal-CHUM

Montreal, Quebec, Canada

VU University Medical Centre

Amsterdam, Netherlands

University Hospital of Zürich

Zurich, Switzerland

Western General Hospital

Edinburgh, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom