EA8211: A Phase III Randomized Trial of Stereotactic ablative radiotherapy (SAbR) for Oligometastatic Advanced Renal Carcinoma (SOAR)

Primary Objective

This phase III trial compares the effect of stero-ablative radiotherapy (SAbR) followed by standard of care systemic therapy, to standard of care systemic therapy alone, in patients with kidney cancer that has spread from where it first started (primary site) to a limited (2-5) number of places in the body (metastatic). Study doctors want to find out if this approach is better or worse than the usual approach for metastatic kidney cancer. The usual approach is defined as the care most people get for metastatic kidney cancer which includes systemic therapy such as immunotherapy (given through the veins) and/or small molecular inhibitor (tablets taken by mouth). Radiotherapy uses high energy x-rays to kill cancer cells and shrink tumors. SAbR uses special equipment to position a patient and deliver radiation to tumors with high precision. Giving SAbR prior to systemic therapy may kill more tumor cells than the usual approach, which is systemic therapy alone.

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Description

PRIMARY OBJECTIVES: I. To compare overall survival (OS) between patients receiving SAbR + systemic therapy (SABR+ST) versus systemic therapy (ST) only. II. To compare average adverse event (AE) score between SAbR+ST arm and ST only arm. SECONDARY OBJECTIVES: I. To compare global health status / quality of life (QOL) between patients receiving SAbR+ST versus ST only. II. To compare progression-free survival (PFS) between the arms.

Details
Age
Adult
Eligibility
Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Locations

Greeley Campus
Harmony Campus
Highlands Ranch Hospital
Medical Center of the Rockies
Poudre Valley Hospital
University of Colorado Hospital

Principal Investigator
Photograph of Tyler Robin

Tyler Robin

Study ID

Protocol Number: 23-2464

More information available at ClinicalTrials.gov: NCT05863351

Categories

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