A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.

Recruiting Phase 3 Interventional Study
Metastatic Tumor
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
180 (estimated)
Sponsor
David Palma · Other
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About This Trial
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 c…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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. Biopsy of metastasis is preferred, but not required. * Total …
Contacts

David Palma, MD, PhD

519-685-8650

David.Palma@lhsc.on.ca

CONTACT