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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 January 2024 |
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Main ID: |
NCT03721341 |
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Date of registration:
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23/10/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors
SABR-COMET 10 |
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Scientific title:
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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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Date of first enrolment:
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February 22, 2019 |
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Target sample size:
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204 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03721341 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Canada
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Netherlands
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Switzerland
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United Kingdom
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Contacts
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Name:
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David Palma, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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London Health Sciences Centre, Lawson Health Research Institute |
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Name:
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Stephen Harrow, MB ChB |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beaston West of Scotland Cancer Centre |
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Name:
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Suresh Senan, MRCP, FRCR |
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Address:
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Telephone:
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Email:
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Affiliation:
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Amsterdam University Medical Centre, VUmc Site |
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Name:
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Robert Olson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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British Columbia Cancer - Centre for the North |
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Key inclusion & exclusion criteria
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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
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Metastatic Tumors
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Intervention(s)
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Radiation: Stereotactic Ablative Radiotherapy
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Drug: Chemotherapy
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Radiation: Palliative Radiation
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Drug: Immunotherapy
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Other: Observation
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Drug: Hormones
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Primary Outcome(s)
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Overall Survival at Study Completion
[Time Frame: At approximately end of year 6 (study completion)]
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Secondary Outcome(s)
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Toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
[Time Frame: End of years 1, 2, 3, 4, 5, and 6 (study completion)]
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Quality of Life as measured by the Functional Assessment of Cancer Therapy- General (FACT-G) questionnaire
[Time Frame: At approximately end of year 6 (study completion)]
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Quality of Life as measured by the EuroQOL Group EQ-5D-5L questionnaire
[Time Frame: At approximately end of year 6 (study completion)]
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Overall Survival at midpoint of Study
[Time Frame: At approximately year 3 (midpoint)]
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Time from randomization to development of new metastatic lesions
[Time Frame: At approximately end of year 6 (study completion)]
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Progression-free Survival
[Time Frame: At approximately year 3, and end of year 6 (study completion)]
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Secondary ID(s)
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SABR-COMET 10
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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