Radioembolization for Kidney Cancer
(ARRCC Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Derek W. Cool

No Placebo Group

Trial Summary

What is the purpose of 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

This trial is for patients with a type of kidney cancer called renal cell carcinoma who cannot undergo surgery and have tumors larger than 4.0 cm. The study aims to enroll 16 participants to assess the effectiveness and safety of a non-surgical treatment over five years.

Inclusion Criteria

I am 18 years old or older.

I am willing to join the study and can sign the consent form.

My kidney cancer is larger than 4 cm but hasn't spread to major veins.

+1 more

Exclusion Criteria

Pregnant or breast-feeding patient

My kidney function is severely impaired, and I am not on dialysis.

Contraindication to arterial renal angiogram, or both CT and MRI contrast medium

+6 more

Participant Groups

The trial is testing Y-90 Selective Internal Radiation Therapy (SIRT), which delivers high doses of radiation directly to large kidney tumors using radioactive spheres, as an alternative treatment for those unable to have surgery.

1Treatment groups

Experimental Treatment

Group I: Y-90 radioembolization treatment armExperimental Treatment1 Intervention

Patients with non-metastatic renal cell carcinoma (RCC) that is \> 4 cm without local invasion (i.e. T1b or T2) who are poor candidates for surgery will have their tumors treated with transarterial radioembolization with Y-90 glass spheres.