Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors
NCT ID: NCT03721341
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
204 participants
INTERVENTIONAL
2019-02-22
2029-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard arm
Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist.
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 Arm
Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.
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).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing to provide informed consent
* Karnofsky performance score greater than 60
* Life expectancy greater than 6 months
* Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
* Controlled primary tumor defined as: at least 3 months since original tumor treated definitively, with no progression at primary site
* Total number of metastases 4-10
* All sites of disease can be safely treated based on a pre-plan
Exclusion Criteria
* For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C)
* Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed below. All such cases must be discussed with one of the study PIs.
* Malignant pleural effusion
* Inability to treat all sites of disease
* Any single metastasis greater than 5 cm in size.
* Any brain metastasis greater than 3 cm in size or a total volume of brain metastases greater than 30 cc.
* Metastasis in the brainstem
* Clinical or radiologic evidence of spinal cord compression
* Dominant brain metastasis requiring surgical decompression
* Metastatic disease that invades any of the following: GI tract (including esophagus, stomach, small or large bowel), mesenteric lymph nodes, or skin
* Pregnant or lactating women
18 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
British Columbia Cancer - Centre for the North
UNKNOWN
Beaston West of Scotland Cancer Centre
UNKNOWN
London Health Sciences Centre
OTHER
David Palma
OTHER
Responsible Party
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David Palma
Principal Investigator
Principal Investigators
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David Palma, MD
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre, Lawson Health Research Institute
Suresh Senan, MRCP, FRCR
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Robert Olson, MD
Role: PRINCIPAL_INVESTIGATOR
British Columbia Cancer - Centre for the North
Stephen Harrow, MB ChB
Role: PRINCIPAL_INVESTIGATOR
Beaston West of Scotland Cancer Centre
Locations
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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
Countries
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References
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Mattes MD, Eubank TD, Almubarak M, Wen S, Marano GD, Jacobson GM, Ma PC. A Prospective Trial Evaluating the Safety and Systemic Response From the Concurrent Use of Radiation Therapy with Checkpoint Inhibitor Immunotherapy in Metastatic Non-Small Cell Lung Cancer. Clin Lung Cancer. 2021 Jul;22(4):268-273. doi: 10.1016/j.cllc.2021.01.012. Epub 2021 Jan 25.
Palma DA, Olson R, Harrow S, Correa RJM, Schneiders F, Haasbeek CJA, Rodrigues GB, Lock M, Yaremko BP, Bauman GS, Ahmad B, Schellenberg D, Liu M, Gaede S, Laba J, Mulroy L, Senthi S, Louie AV, Swaminath A, Chalmers A, Warner A, Slotman BJ, de Gruijl TD, Allan A, Senan S. Stereotactic ablative radiotherapy for the comprehensive treatment of 4-10 oligometastatic tumors (SABR-COMET-10): study protocol for a randomized phase III trial. BMC Cancer. 2019 Aug 19;19(1):816. doi: 10.1186/s12885-019-5977-6.
Other Identifiers
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SABR-COMET 10
Identifier Type: -
Identifier Source: org_study_id
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