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Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors
Sponsor: David Palma
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
Conditions
Interventions
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.
Chemotherapy
Chemotherapy may be given as indicated.
Immunotherapy
Immunotherapy may be given as indicated.
Hormones
Hormones may be given as indicated.
Observation
Observation only is acceptable if this is the standard practice.
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