Status:
ACTIVE_NOT_RECRUITING
Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET)
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
London Regional Cancer Program, Canada
VU University of Amsterdam
Conditions:
Metastatic Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Stereotactic Ablative Radiotherapy (SABR) is a new radiation treatment that delivers high-dose, precise radiation to small tumors in 1-3 weeks of treatment. This new technique can potentially allow ra...
Detailed Description
TREATMENT PLAN 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 al...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT01446744
Start Date
November 1 2011
End Date
June 1 2026
Last Update
October 5 2023
Active Locations (10)
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1
Alfred Health, William Burkland Radiotherapy Centre
Melbourne, Victoria, Australia, 3004
2
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z4E6
3
Atlantic Clinical Cancer Research , QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
4
Juravinski Cancer Centre, Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2