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Radioembolization

Radioembolization for Kidney Cancer (ARRCC Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Derek W. Cool
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Biopsy confirmed RCC > 4.0 cm and no renal vein or IVC involvement (T1b or T2 disease)
Not suitable for or declining standard of care nephrectomy or partial nephrectomy
Must not have
Severely impaired renal function (GFR ≤ 30) and not on dialysis
Evidence of metastatic disease on CT or MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment until 5-years post-therapy
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to test a new treatment for kidney cancer patients who cannot have surgery due to large tumors. The treatment involves using radioactive spheres containing Y-90 to deliver high doses of radiation to the tumors

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include localized pain, nausea, fatigue, changes in liver function tests, possible damage to nearby organs due to radiation exposure, and general risks associated with radiological procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney cancer is larger than 4 cm but hasn't spread to major veins.
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I am not a candidate for or am choosing not to have standard kidney surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is severely impaired, and I am not on dialysis.
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My scans show cancer has spread to other parts of my body.
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My treatment involves a lung radiation dose higher than recommended.
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I have kidney cancer on both sides and no plans to treat the cancer on the opposite side.
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I have had kidney radiation or immune system/TKI cancer treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment until 5-years post-therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment until 5-years post-therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Oncologic tumor response at 12 months
Secondary study objectives
Change in Split Renal Function
Change in renal volume and morphology post-therapy
Impact on global renal function
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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Who is running the clinical trial?

Derek W. CoolLead Sponsor
Boston Scientific CorporationIndustry Sponsor
741 Previous Clinical Trials
856,891 Total Patients Enrolled
~11 spots leftby Dec 2028
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