NL-OMON37922
Completed
Phase 2
Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET): A Randomized Phase II Trial - SABR-COMET
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- cancer spread to other parts of the body
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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\.
- •Controlled primary tumor, 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 chemotherapy (cytotoxic or molecularly targeted agents) therapy 4 weeks prior to first fraction of radiotherapy, during radiotherapy, or for two weeks after last fraction. Hormonal therapy is allowed.
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 MRI.
- •Dominant brain metastasis requiring surgical decompression
- •Pregnant or lactating women
Outcomes
Primary Outcomes
Not specified
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