Actively Recruiting
A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.
Led by David Palma · Updated on 2025-12-31
180
Participants Needed
5
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a phase III multi-institutional randomized trial. Patients will be randomized in a 1:2 ratio between current standard of care treatment (Arm 1) vs. standard of care treatment + SABR (Arm 2) to sites of known disease. Patients will be stratified by two of the strongest prognostic factors, based on a large multi-institutional analysis3: histology (Group 1: hormone-sensitive prostate cancer, breast, or renal; Group 2: all others), and number of metastases (Group 1: 1-3; Group 2: 4-10).
CONDITIONS
Official Title
A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Willing to provide informed consent
- Karnofsky performance status > 60
- Life expectancy > 6 months
- Histologically confirmed malignancy with metastatic disease detected on imaging
- Total number of metastases 1-10 at enrollment with a primary tumor present
- Restaging completed within 12 weeks prior to randomization
- No computed tomography changes suggesting fibrotic interstitial lung disease if receiving thoracic radiotherapy
- 10 or fewer lifetime metastases from the cancer for which participants are enrolled
You will not qualify if you...
- Serious medical comorbidities preventing radiotherapy such as interstitial lung disease requiring thoracic radiation, Crohn's disease if gastrointestinal tract will receive radiotherapy, ulcerative colitis if bowel will receive radiotherapy, or connective tissue disorders like lupus or scleroderma
- Moderate or severe liver dysfunction (Child Pugh B or C) in patients with liver metastases
- Substantial overlap with a previously treated radiation volume exceeding dose constraints
- Malignant pleural effusion
- Inability to treat all sites of disease
- Brain metastasis larger than 3 cm or total brain metastases volume greater than 30 cc
- Metastasis in the brainstem
- Clinical or radiologic evidence of spinal cord compression
- Metastatic disease invading the gastrointestinal tract or skin
- Pregnant or lactating women
AI-Screening
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Trial Site Locations
Total: 5 locations
1
BC Cancer - Centre for the North
Prince George, British Columbia, Canada, V2M 7E9
Not Yet Recruiting
2
BC Cancer - Vancouver
Vancouver, British Columbia, Canada, V5Z 4C2
Actively Recruiting
3
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, Canada, N6A 5W9
Actively Recruiting
4
Centre Hospitalier de l'Université de Montréal-CHUM
Montreal, Quebec, Canada, H2X 0C1
Actively Recruiting
5
Universitätsspital Zürich
Zurich, Switzerland
Actively Recruiting
Research Team
D
David Palma, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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