Ablative Radioembolization of Renal Cell Carcinoma Trial

Oncologic tumor response at 12 months

Assessment the cancer treatment response within the 12 months after treatment. Oncologic response will be based on the modified RECIST (mRECIST) criteria.

Treatment-related Adverse Events

Clinician assessment will occur at 4-weeks, 3-months, 6-months \& 12-months post-treatment and annually to 5 years. All adverse events will be categorized and graded based on Common Terminology Criteria for Adverse Events (CTCAE) grading system. All adverse events will be further classified based on relatedness to either a) the Therapeutic Intervention and b) Y-90 Radiation Dose by the following: a) unrelated, b) unlikely to be related, c) possibly related, d) probably related, e) definitely related. Therapeutic Intervention: Includes all procedure-related adverse events during the planning angiogram or Y-90 therapy procedures (all Y-90 Radiation Dose adverse events included as well). Y-90 Radiation Dose: Subset of Therapeutic Intervention that includes only those adverse events related to the Y-90 radiation therapy. Examples of dose-related events might include post-procedure fatigue/malaise, radiation colitis, acute kidney injury not related to a catheter arterial injury.

Safety and tolerability of ablative doses (400-600 Gy) of Y-90 spheres administered in the kidney

Tolerability of the radiation will be characterized by dose-limiting toxicity (DLT) events. The DLT review period will be 30 days after Y-90 procedure. Any serious adverse event that is possibly, probably or definitely related to Y-90 Radiation Dose will be classified as a dose-limiting toxicity (DLT) event. Complications related only to catheter arterial embolization procedure (example puncture site bleeding, artery dissection, etc) or the planning angiogram will not be considered a DLT. Greater \> 1 in 6 patients experiencing DLT events will declare the maximally administered dose and require a reduction in the target dose to 300 Gy. If no DLT events occur during the DLT review period for the first three patients or 1 in the first 6 patients, then the tumour target dose for future participants can be increased up to a maximum of 600 Gy (range 400-600 Gy) at the treating physician's discretion.

Impact on global renal function

Assessment of global renal function will be based on the glomerular filtration rate (GFR), calculated using the CKD-EPI Creatinine Equation (2021). GFR will be collected at baseline and at each clinical follow-up post-therapy to assess for change.

Patient-reported outcomes

Patient-defined symptomatic adverse events: Self-reported by participants using the National Cancer Institute's Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) form. Overall Side Effect Impact: Measured by the Functional Assessment of Cancer Therapy-GP5 (FACT-GP5) question from the FACT-G questionnaire - "I am bothered by side effects of treatment". Pain intensity measured by 11-point Numerical Pain Rating Score. Health-related quality of life measures: Quality of life and health utility will be self-reported using the EuroQol Group EQ-5D-5L form. This 5-level form evaluates 5 dimensions of (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and can generate a global preference-based score that can be used to estimate quality-adjusted life years (QALY) within the Canadian population context to facilitate cost-utility analysis.