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Clinical Trial NCT01446744 (SABR-COMET) for Metastatic Tumors is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET) Phase 2 99 Overall Survival
6.0.1 Standard Arm (Arm 1)
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Patients in this arm should not receive stereotactic doses or radiotherapy boosts.
Treatment recommendations are as follows:
Brain: Whole brain radiotherapy i.e....
Show MoreStereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET): A Randomized Phase II Trial
- SABR-COMET
- R-11-605
- SABR-COMET (Other Identifier) (OCREB)
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorStandard arm Standard of care, palliative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist | palliative radiotherapy Investigators should follow the principles of palliative radiotherapy as per the individual institution. Treatment recommendations are as follows:
Brain: Whole brain radiotherapy i.e. 20 Gy in 5 fractions, 30 Gy in 10 fractions
Lung: Palliative radiotherapy as per 2011 consensus guidelines.15 i.e. 8 Gy in 1 fraction, 20 Gy in 5 fractions, 30 Gy in 10 fractions
Bone: Palliative radiotherapy as per 2011 consensus gu...Show More |
ExperimentalStereotactic arm Stereotactic ablative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist | Stereotactic ablative radiotherapy Total dose and number of fractions will depend on the site of disease. Treatment will be given daily, or every other day, over 1 -3 weeks. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Overall Survival | At approximately end of year 4 (study completion) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Quality of life: Assessed with the Functional Assessment of Cancer Therapy: General (FACT-G) | At approximately end of year 2, and end of year 4 (study completion) | |
Toxicity: Assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4 for each organ treated (e.g. liver, lung, bone) | At approximately the end of years 1, 2, 3, and 4 (study completion) | |
Progression-free survival | At approximately end of year 2, and end of year 4 (study completion) | |
Lesional control rate | At approximately end of year 2, and end of year 4 (study completion) | |
Number of cycles of further chemotherapy/systemic therapy | At approximately end of year 2, and end of year 4 (study completion) |
Age 18 or older
Willing to provide informed consent
Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
ECOG performance status 0-1
Controlled primary tumor
a. defined as: at least 3 months since original tumor treated definitively, with no progression at primary site
All sites of disease can be safely treated based on criteria below
Maximum 3 metastases in any single organ system (i.e. lung, liver, brain, bone)
Life expectancy >6 months
Not a candidate for surgical resection at all sites: surgery to all sites not recommended by multidisciplinary team, or unfit or declining surgery
Prior chemotherapy allowed but no systemic therapy 4 weeks prior to first fraction of radiotherapy, during radiotherapy, or for two weeks after last fraction
Patients with metastases that have been previously treated (e.g. prior resection, Radiofrequency Ablation (RFA) or radiotherapy):
a. If that previously treated metastasis is controlled on imaging, the patient is eligible for this study and that site does not need treatment
a. If that previously treated metastasis is NOT controlled on imaging:
- If the previous treatment was surgery, the patient is eligible if that site can be treated by SABR
- If the previous treatment was radiotherapy or RFA, the patient is ineligible.
Patient presented at multidisciplinary tumor board or quality-assurance rounds.
- Serious medical comorbidities precluding radiotherapy
- Bone metastasis in a femoral bone
- Patients with 1-3 brain metastasis and no disease elsewhere (these patients should not be randomized but treated with stereotactic radiotherapy as per results of randomized trials)
- Prior radiotherapy to a site requiring treatment
- Complete response to first-line chemotherapy (i.e. no measurable target for SABR)
- Malignant pleural effusion
- Inability to treat all sites of active disease
- Clinical or radiologic evidence of spinal cord compression OR tumor within 3 mm of spinal cord on Magnetic Resonance Imaging (MRI).
- Dominant brain metastasis requiring surgical decompression
- Pregnant or lactating women
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's- London Regional Cancer Program, Canada
- VU University of Amsterdam
British Columbia
Nova Scotia
Ontario
Prince Edward Island
Quebec
Victoria