Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET) (SABR-COMET)
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ClinicalTrials.gov Identifier: NCT01446744 |
Recruitment Status :
Active, not recruiting
First Posted : October 5, 2011
Last Update Posted : October 5, 2023
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Condition or disease | Intervention/treatment | Phase |
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Metastatic Tumors | Radiation: Stereotactic ablative radiotherapy Radiation: palliative radiotherapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 99 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET): A Randomized Phase II Trial |
Study Start Date : | November 2011 |
Estimated Primary Completion Date : | June 2026 |
Estimated Study Completion Date : | June 2026 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Standard arm
Standard of care, palliative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist
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Radiation: 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 guidelines.16 i.e. 8 Gy in 1 fraction (most common), 20 Gy in 5 fractions, 30 Gy in 10 fractions Liver: 20 Gy in 5 fractions if standard institutional practice |
Experimental: Stereotactic arm
Stereotactic ablative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist
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Radiation: 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. |
- Overall Survival [ Time Frame: At approximately end of year 4 (study completion) ]
- Quality of life: Assessed with the Functional Assessment of Cancer Therapy: General (FACT-G) [ Time Frame: 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) [ Time Frame: At approximately the end of years 1, 2, 3, and 4 (study completion) ]
- Progression-free survival [ Time Frame: At approximately end of year 2, and end of year 4 (study completion) ]
- Lesional control rate [ Time Frame: At approximately end of year 2, and end of year 4 (study completion) ]
- Number of cycles of further chemotherapy/systemic therapy [ Time Frame: At approximately end of year 2, and end of year 4 (study completion) ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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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
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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.
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446744
Australia, Victoria | |
Alfred Health, William Burkland Radiotherapy Centre | |
Melbourne, Victoria, Australia, 3004 | |
Canada, British Columbia | |
BC Cancer Agency | |
Vancouver, British Columbia, Canada, V5Z4E6 | |
Canada, Nova Scotia | |
Atlantic Clinical Cancer Research , QEII Health Sciences Centre | |
Halifax, Nova Scotia, Canada, B3H 1V7 | |
Canada, Ontario | |
Juravinski Cancer Centre, Hamilton Health Sciences | |
Hamilton, Ontario, Canada, L8V 5C2 | |
London Regional Cancer Program of the Lawson Health Research Institute | |
London, Ontario, Canada, N6A 4L6 | |
Ottawa Cancer Centre | |
Ottawa, Ontario, Canada | |
Canada, Prince Edward Island | |
PEI Cancer Treatment Center | |
Charlottetown, Prince Edward Island, Canada, C1A 8T5 | |
Canada, Quebec | |
McGill University Health Centre Research Institute | |
Montreal, Quebec, Canada, H3H 1A4 | |
Netherlands | |
VU University Amsterdam (VUmc) | |
Amsterdam, Netherlands | |
United Kingdom | |
The Beatson West of Scotland Cancer Centre | |
Glasgow, United Kingdom |
Principal Investigator: | David Palma, MD, PhD | London Regional Cancer Program of the Lawson Health Research Institute | |
Principal Investigator: | Suresh Senan, MRCPFRCR,PhD | Amsterdam UMC, location VUmc |
Responsible Party: | David Palma, Principal Investigator, Lawson Health Research Institute |
ClinicalTrials.gov Identifier: | NCT01446744 |
Other Study ID Numbers: |
R-11-605 SABR-COMET ( Other Identifier: OCREB ) |
First Posted: | October 5, 2011 Key Record Dates |
Last Update Posted: | October 5, 2023 |
Last Verified: | October 2023 |
Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes |