High-Dose Yttrium-90 Radioembolization Treatment for Large Non-Metastatic Renal Cell Carcinoma in Patients Unsuitable for Surgery

What this Trial Is About

Renal cell carcinoma RCC is the most common type of kidney cancer and usually treated with surgery. However, for patients who cannot undergo surgery and have tumors larger than 4.0 cm, there is no established therapy. Researchers are evaluating Yttrium-90 Y-90 radioembolization, a treatment delivering targeted internal radiation, to see if it can effectively treat these larger RCC tumors. This phase II study aims to assess the tumor response one year after treatment and monitor safety and kidney function over five years. Participants will receive Y-90 radioembolization using glass spheres injected into the arteries supplying their RCC tumors. This internal radiation aims to deliver a high dose directly to the tumor while minimizing exposure to nearby organs. The study focuses on patients with localized RCC larger than 4 cm who are not candidates for surgery or have declined it. The treatment will be given once, and participants will be followed for up to five years to assess long-term cancer control and safety. During the study, participants will undergo regular assessments including imaging scans at enrollment, 3 months, and 12 months post-treatment to measure tumor response. Kidney function will be monitored at multiple time points up to five years. Patient-reported outcomes will be collected shortly after treatment, and safety evaluations will be conducted throughout the follow-up period. The main outcome is tumor response at 12 months, with additional measures including adverse events, kidney function changes, and survival rates tracked over the five-year period.

Ablative Radioembolization of Renal Cell Carcinoma Trial