Radioembolization for Kidney Cancer

(ARRCC Trial)

Overseen By Sarah DeBrabandere, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Derek W. Cool

Must not be taking: Immunotherapy, TKIs

Disqualifiers: Metastatic disease, Impaired renal function, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

16 Participants Needed

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Y-90 Selective Internal Radiation Therapy (SIRT) for kidney cancer?

While there is no direct evidence for kidney cancer, Y-90 SIRT has shown effectiveness in treating liver tumors and metastases from other cancers, suggesting potential benefits for kidney cancer. The treatment involves delivering radiation directly to the tumor, which has been effective in shrinking tumors and improving outcomes in other cancer types. ^{1 2 3 4 5}

Is Y-90 radioembolization generally safe for humans?

Y-90 radioembolization, also known as selective internal radiation therapy (SIRT), has been used safely in humans for treating liver tumors and other cancers. Studies have shown it to be a promising and minimally invasive treatment with confirmed safety over the past two decades, although it may have side effects and requires careful management. ^{1 5 6 7 8}

How is the treatment Y-90 Selective Internal Radiation Therapy (SIRT) unique for kidney cancer?

Y-90 Selective Internal Radiation Therapy (SIRT) is unique for kidney cancer because it involves delivering radiation directly to the tumor through tiny beads injected into the blood vessels feeding the tumor, which is different from traditional treatments that may not target the tumor as precisely. This approach is being explored for kidney cancer that cannot be treated with conventional methods. ^{1 2 3 5 9}

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Y-90 radioembolization therapy for renal cell carcinoma

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and oncologic response after Y-90 therapy

5 years

Regular visits at 1 month, 3 months, 6 months, 12 months, and annually up to 5 years

Treatment Details

Interventions

• Y-90 Selective Internal Radiation Therapy (SIRT)

Trial Overview 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.

Participant Groups

Group I: Y-90 radioembolization treatment arm Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Derek W. Cool

Lead Sponsor

Trials

1

Recruited

20+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Findings from Research

Selective internal radiotherapy (SIRT) with yttrium-90 can lead to significant tumor response in patients with hepatic malignancies, allowing for subsequent liver resection in selected cases, as demonstrated by a mean lesion volume reduction of 475 cm³ in 12 patients.

While SIRT is generally safe with no complications noted post-treatment, the study found a 67% morbidity rate and 11% mortality rate within 90 days after surgery, highlighting the need for careful patient selection and further research to optimize outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver Resection After Selective Internal Radiation Therapy with Yttrium-90: Safety and Outcomes. Mafeld, S., Littler, P., Hayhurst, H., et al.[2020]

Selective internal radiotherapy (SIRT) using yttrium-90 microspheres can enhance clinical outcomes for patients with inoperable liver cancer by targeting tumors while protecting healthy tissue.

Effective planning for SIRT is crucial to avoid serious side effects like radiation-induced liver disease, and it is recommended to use multiple planning methods to determine the appropriate microsphere activity for each patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient selection and activity planning guide for selective internal radiotherapy with yttrium-90 resin microspheres. Lau, WY., Kennedy, AS., Kim, YH., et al.[2022]

Yttrium-90 (90Y) hepatic radioembolization showed promising efficacy in treating liver-dominant metastatic renal cell carcinoma (RCC) in six patients who were resistant to previous therapies, with three achieving complete responses and one a partial response over a follow-up period of up to 64 months.

The treatment was generally safe, with only mild toxicities (grades 1 and 2) reported, primarily fatigue, indicating that 90Y radioembolization could be a viable option for patients with limited treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yttrium-90 radioembolization of renal cell carcinoma metastatic to the liver. Abdelmaksoud, MH., Louie, JD., Hwang, GL., et al.[2012]

Selective internal yttrium-90 radioembolization therapy ((90)Y-SIRT) is an effective and safe minimally invasive treatment for liver malignant tumors, supported by clinical applications over the past two decades and recognized by major cancer treatment guidelines.

A consensus was formed by experts from various medical fields to standardize the management and treatment procedures for (90)Y-SIRT, addressing critical aspects such as indications, contraindications, postoperative follow-up, and radiation safety, to enhance treatment safety and success rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Chinese expert consensus on selective internal radiation therapy with yttrium-90 for primary and metastatic hepatocellular carcinoma]. [2021]

In a study of 27 patients with unresectable hepatocellular carcinoma (HCC) treated with yttrium-90 selective internal radiation therapy (90Y-SIRT), the treatment was well-tolerated with no Grade 3-4 clinical toxicities reported, although 38% experienced significant laboratory toxicities within 3 months.

Patients with higher pretreatment bilirubin or transaminase levels were found to be at increased risk for worsening liver function after treatment, indicating the need for careful monitoring in these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and Predictors of Toxicity after Selective Internal Radiation Therapy Using Yttrium-90 Resin Microspheres for Unresectable Hepatocellular Carcinoma. Gabrielson, A., Miller, A., Banovac, F., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

RESIRT: A Phase 1 Study of Selective Internal Radiation Therapy Using Yttrium-90 Resin Microspheres in Patients With Primary Renal Cell Carcinoma. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Liver Resection for Colorectal Hepatic Metastases after Systemic Chemotherapy and Selective Internal Radiation Therapy with Yttrium-90 Microspheres: A Systematic Review. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Liver Resection After Selective Internal Radiation Therapy with Yttrium-90: Safety and Outcomes. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Patient selection and activity planning guide for selective internal radiotherapy with yttrium-90 resin microspheres. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of Yttrium-90 selective internal radiation therapy on non-conventional liver tumors. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Yttrium-90 radioembolization of renal cell carcinoma metastatic to the liver. [2012]

7. China pubmed.ncbi.nlm.nih.gov

[Chinese expert consensus on selective internal radiation therapy with yttrium-90 for primary and metastatic hepatocellular carcinoma]. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Outcomes and Predictors of Toxicity after Selective Internal Radiation Therapy Using Yttrium-90 Resin Microspheres for Unresectable Hepatocellular Carcinoma. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

[Selective internal radioembolization in nonresectable hepatocellular carcinoma]. [2018]