Ablative Radioembolization of Renal Cell Carcinoma Trial

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDerek W. Cool

About this trial

Renal cell carcinoma (RCC), the most common type of kidney cancer, is typically treated with surgery; however, there is no established therapy for patients who are not surgical candidates and who have tumours greater than 4.0 cm in size. Selective internal radiation therapy (SIRT) or radioembolization using radioactive spheres containing 90-Yttrium (Y-90) is successful at treating large tumours with high doses of radiation within the liver and might be similarly effective for treating larger RCC tumours in patients, particularly those who are not surgical candidates.

This prospective study will enroll 16 participants with RCC who are not candidates for surgery and treat them with Y-90 radioembolization using a high-dose therapy to see if it is an effective cancer therapy. Primary outcome will be RCC treatment response 1 year after the Y-90 radioembolization. Additionally, the safety, tolerability, and impact on kidney function of the therapy will be monitored for all participants. Patients will be followed for a total of 5 years to evaluate long-term outcome in cancer control and safety of the treatment.

Eligibility criteria

Qualifiers

Patients willing to participate and provide written consent

Patients 18 years of age and older

Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2

Biopsy confirmed RCC > 4.0 cm and no renal vein or IVC involvement (T1b or T2 disease)

Disqualifiers

Evidence of metastatic disease on CT or MRI

Severely impaired renal function (GFR ≤ 30 mL/min/1.73m²) and not on dialysis

Bilateral RCC without plan for definitive therapy of the contralateral lesion

RCC that is locally recurrent at prior surgery or ablation site (new location in same or contralateral kidney is permitted)

Trial design

Treatments tested in this trial

  • Y-90 Selective Internal Radiation Therapy (SIRT)

Treatment groups

16 Participants
are divided into 1 treatment group

Sponsors and collaborators

Derek W. Cool

Lead sponsor

Western University, Canada

Sponsor institution

Boston Scientific Corporation

Collaborator