Actively Recruiting
Ablative Yttrium-90 Radioembolization Therapy for Non-Metastatic Renal Cell Carcinoma ARRCC Trial
Led by Derek W. Cool · Updated on 2025-07-20
16
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
Sponsors
D
Derek W. Cool
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Ablative Radioembolization of Renal Cell Carcinoma Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients willing to participate and provide written consent
- Patients 18 years of age and older
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
- Biopsy confirmed RCC larger than 4.0 cm without renal vein or IVC involvement (T1b or T2 disease)
- Not suitable for or declining standard of care nephrectomy or partial nephrectomy
- Adequate liver function with AST and ALT less than 2.5 times upper limit of normal (or less than 5 times ULN if liver metastases present)
- Total bilirubin less than 3 times upper limit of normal
- Serum albumin 3.0 g/dL or higher unless prothrombin time is normal
- Adequate blood counts with hemoglobin 8.0 g/dL or higher, neutrophils at least 1000 cells/µL, and platelets over 50 x 10^9/L
- Women of childbearing potential with negative pregnancy test and agreement to use effective contraception during and after treatment
- Sexually active men must use condoms during treatment and for specified times after, and agree to effective contraception if partners are women of childbearing potential
You will not qualify if you...
- Evidence of metastatic disease on CT or MRI
- Severely impaired kidney function with GFR 30 mL/min/1.73m² or less and not on dialysis
- Bilateral RCC without plan for definitive therapy of the other kidney lesion
- RCC that is locally recurrent at prior surgery or ablation site
- Prior or current kidney radiation therapy or systemic immunotherapy/tyrosine kinase inhibitors
- Lung radiation dose above safety limits
- Lack of blood flow to parts of the tumor making treatment ineffective
- Contraindication to arterial renal angiogram or CT/MRI contrast medium
- Severe allergy to contrast or study products not manageable medically
- Chronic lung disease with low oxygen saturation or requiring home oxygen
- Congestive heart failure with low ejection fraction below 40%
- Active infection considered clinically significant
- Severe or unstable chronic conditions posing unacceptable risk
- Life expectancy less than 1 year
- Pregnant or breastfeeding women
Research Team
S
Sarah DeBrabandere, PhD
C
Craig Johnson, PhD
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