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Brief Title: Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors
Official Title: A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10)
Study ID: NCT03721341
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Alfred Health, Melbourne, Victoria, Australia
BC Cancer Agency, Vancouver Island Centre, Victoria, British Columbia, Canada
Nova Scotia Health Authortiy, Halifax, Nova Scotia, 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
Health Sciences North, Sudbury, Ontario, Canada
University Health Network, Toronto, Ontario, Canada
Centre hospitalier de l'Université de Montréal-CHUM, Montréal, Quebec, Canada
VU University Medical Centre, Amsterdam, , Netherlands
University Hospital of Zürich, Zürich, , Switzerland
Western General Hospital, Edinburgh, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Name: David Palma, MD
Affiliation: London Health Sciences Centre, Lawson Health Research Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Suresh Senan, MRCP, FRCR
Affiliation: Amsterdam University Medical Centre, VUmc Site
Role: PRINCIPAL_INVESTIGATOR
Name: Robert Olson, MD
Affiliation: British Columbia Cancer - Centre for the North
Role: PRINCIPAL_INVESTIGATOR
Name: Stephen Harrow, MB ChB
Affiliation: Beaston West of Scotland Cancer Centre
Role: PRINCIPAL_INVESTIGATOR