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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03721341
Registration number
NCT03721341
Ethics application status
Date submitted
23/10/2018
Date registered
26/10/2018
Date last updated
13/12/2023
Titles & IDs
Public title
Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors
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Scientific title
A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10)
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Secondary ID [1]
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SABR-COMET 10
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Universal Trial Number (UTN)
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Trial acronym
SABR-COMET 10
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Palliative Radiation
Treatment: Drugs - Chemotherapy
Treatment: Drugs - Immunotherapy
Treatment: Drugs - Hormones
Other interventions - Observation
Treatment: Other - Stereotactic Ablative Radiotherapy
Active Comparator: Standard arm - Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist.
Experimental: Stereotactic Arm - Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.
Treatment: Other: 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.
Treatment: Drugs: Chemotherapy
Chemotherapy may be given as indicated.
Treatment: Drugs: Immunotherapy
Immunotherapy may be given as indicated.
Treatment: Drugs: Hormones
Hormones may be given as indicated.
Other interventions: Observation
Observation only is acceptable if this is the standard practice.
Treatment: Other: 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).
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Intervention code [3]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival at Study Completion
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Assessment method [1]
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Time from randomization to death from any cause.
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Timepoint [1]
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At approximately end of year 6 (study completion)
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Secondary outcome [1]
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Progression-free Survival
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Assessment method [1]
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Time from randomization to disease progression at any site or death.
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Timepoint [1]
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At approximately year 3, and end of year 6 (study completion)
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Secondary outcome [2]
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Time from randomization to development of new metastatic lesions
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Assessment method [2]
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New metastatic lesions will be detected using computed tomography, magnetic resonance imaging, and/or bone scans.
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Timepoint [2]
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At approximately end of year 6 (study completion)
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Secondary outcome [3]
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Quality of Life as measured by the Functional Assessment of Cancer Therapy- General (FACT-G) questionnaire
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Assessment method [3]
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Timepoint [3]
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At approximately end of year 6 (study completion)
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Secondary outcome [4]
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Quality of Life as measured by the EuroQOL Group EQ-5D-5L questionnaire
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Assessment method [4]
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Timepoint [4]
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At approximately end of year 6 (study completion)
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Secondary outcome [5]
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Toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
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Assessment method [5]
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Timepoint [5]
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End of years 1, 2, 3, 4, 5, and 6 (study completion)
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Secondary outcome [6]
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Overall Survival at midpoint of Study
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Assessment method [6]
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Timepoint [6]
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At approximately year 3 (midpoint)
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Eligibility
Key inclusion criteria
- Age 18 or older
- 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Serious medical comorbidities precluding radiotherapy. These include interstitial lung
disease in patients requiring thoracic radiation, Crohn's disease in patients where
the GI tract will receive radiotherapy, and connective tissue disorders such as lupus
or scleroderma.
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/02/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2029
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Actual
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Sample size
Target
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Accrual to date
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Final
204
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Health - Melbourne
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Recruitment postcode(s) [1]
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3181 - Melbourne
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Recruitment outside Australia
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Canada
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State/province [1]
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British Columbia
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Canada
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State/province [2]
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Netherlands
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Amsterdam
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Switzerland
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Zürich
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United Kingdom
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Edinburgh
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United Kingdom
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State/province [8]
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Glasgow
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Funding & Sponsors
Primary sponsor type
Other
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Name
David Palma
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Amsterdam University Medical Centre, VUmc Site
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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British Columbia Cancer - Centre for the North
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Beaston West of Scotland Cancer Centre
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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London Health Sciences Centre
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Address [4]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03721341
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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David Palma, MD
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Address
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London Health Sciences Centre, Lawson Health Research Institute
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03721341
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