Radioembolization for Kidney Cancer

(ARRCC Trial)

Overseen By Craig Johnson, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating kidney cancer using radioembolization, where tiny radioactive beads target large tumors in the kidney. The focus is on patients with renal cell carcinoma (RCC) who cannot undergo surgery and have tumors larger than 4 cm. The aim is to determine if Y-90 Selective Internal Radiation Therapy (SIRT) can effectively shrink tumors and assess its impact on kidney function and overall health over time. Suitable candidates have kidney cancer that has not spread and are not eligible for surgery. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

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 prior data suggests that this radioembolization technique is safe for treating kidney cancer?

Research has shown that Y-90 Selective Internal Radiation Therapy (SIRT) is generally well-tolerated by patients. Studies have found that SIRT can be safely used in individuals with kidney cancer who are not candidates for surgery. This treatment delivers tiny radioactive beads directly to the tumor, targeting cancer cells while sparing most healthy tissue.

In previous studies, patients did not experience severe side effects at any dose of Y-90, indicating that the treatment did not cause major harm, even in larger amounts. Experts agree that it can be safely combined with other cancer treatments.

Although researchers continue to study SIRT for kidney cancer, the evidence so far suggests it is a safe option for patients unable to undergo surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for kidney cancer?

Unlike the standard treatments for kidney cancer, which often include surgery, immunotherapy, or targeted therapies, Y-90 Selective Internal Radiation Therapy (SIRT) offers a novel approach by using radioactive Yttrium-90 glass spheres. This treatment is unique because it delivers radiation directly to the tumor through the bloodstream, allowing for a more precise attack on cancer cells while sparing surrounding healthy tissue. Researchers are excited about this approach because it could be a game-changer for patients who are poor candidates for surgery, potentially offering them an effective alternative with fewer side effects.

What evidence suggests that Y-90 radioembolization might be an effective treatment for kidney cancer?

Research has shown that Y-90 Selective Internal Radiation Therapy (SIRT), which participants in this trial will receive, can help treat large tumors. This treatment uses tiny beads to deliver high doses of radiation directly to the tumor, aiding in cancer shrinkage. In studies with patients who have kidney cancer, most saw their cancer remain stable, and some experienced tumor reduction. Early results also suggest that patients generally tolerate this treatment well. Overall, evidence indicates that Y-90 SIRT could be a promising option for those unable to undergo surgery. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 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.

I am not a candidate for or am choosing not to have standard kidney surgery.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06642220

Ablative Radioembolization of Renal Cell Carcinoma Trial ... Selective internal radiation therapy (SIRT) or radioembolization using radioactive spheres containing 90-Yttrium (Y-90) is successful at treating large tumours ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35710899/

A Phase 1 Study of Selective Internal Radiation Therapy ... This study demonstrated good tolerability of SIRT at all dose levels including "imminent stasis" in treating primary tumours in RCC patients otherwise ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/65/supplement_2/24103

Evaluating the Effectiveness of Treating Renal Cell Carcinoma ... Using 90Y SIRT enables physicians to deliver a high-absorbed dose directly to the tumor with a precisely placed catheter; this allows for ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1558767322001112

RESIRT: A Phase 1 Study of Selective Internal Radiation ... Best overall tumour responses were partial response in 4.8%, stable disease in 90.5%, and progressive disease in 4.8% of patients, suggesting that SIRT with Y- ...

5. careacross.com careacross.com/clinical-trials/trial/NCT06642220

Ablative Radioembolization of Renal Cell Carcinoma Trial Selective internal radiation therapy (SIRT) or radioembolization using radioactive spheres containing 90-Yttrium (Y-90) is successful at treating large tumours ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06642220

Ablative Radioembolization of Renal Cell Carcinoma Trial Selective internal radiation therapy (SIRT) or radioembolization using radioactive spheres containing 90-Yttrium (Y-90) is successful at treating large tumours ...

7. jgo.amegroups.org jgo.amegroups.org/article/view/16905/html

Safety of selective internal radiation therapy with yttrium-90 ... This paper provides current clinical experiences and expert consensus guidelines for the use of SIRT in combination with the anticancer treatment agents.