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Yttrium-90 (Y90) Radioembolization for the Treatment of Early Stage Renal Cell Carcinoma, The RENEGADE Trial

ConditionsStage I Renal Cell CancerStage II Renal Cell Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonsson Comprehensive Cancer Center

About this trial

This phase I/II trial tests the safety, side effects and effectiveness of radioembolization with yttrium-90 (Y-90) in patients with early stage renal cell carcinoma. Y-90 is a radioactive chemical that is incorporated into millions of very tiny glass spheres. These spheres are injected into the artery that feeds the cancer. This process is called radioembolization. Y-90 radioembolization may be a safe and effective treatment for patients with early stage renal cell carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must be aged ≥ 18 years at the time of screening

Written informed consent and any locally required authorization (e.g., Health Insurance Portability and accountability Act) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations

Life expectancy ≥ 12 months

RCC, diagnosed by radiographic imaging and histology

Disqualifiers

Any contraindication to angiography or selective renal artery catheterization

Screening angiography with cone beam CT (CBCT) shows any arterial flow to the gastrointestinal tract uncorrectable by angiographic techniques

Screening angiography with CBCT shows poor tumor targeting that would lead to a dose that does not meet the renal dosing criteria. This typically occurs when a feeding artery to the tumor cannot be identified

Screening angiography demonstrates excessive non-tumoral renal parenchyma will be in the treatment field, that the new baseline glomerular filtration rate will be < 45 mL/min/1.73 m²

Trial design

Design model

Single group

Treatments tested in this trial

  • Angiogram

    Procedure/Surgery

    Undergo angiogram

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Radioembolization

    Radiation

    Undergo radioembolization

  • Single Photon Emission Computed Tomography

    Procedure/Surgery

    Undergo SPECT

  • Survey Administration

    Other intervention

    Ancillary study

  • Yttrium Y 90 Glass Microspheres

    Radiation

    Given intra-arterially

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Treatment (radioembolization, TheraSphere)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Number of treatment related adverse events

Time frame
Up to 2 years
2

Number of serious adverse events

Time frame
Up to 2 years

Secondary outcomes

1

Overall response rate (ORR)

According to Choi, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and modified RECIST. Will be summarized as count and percentage. The corresponding 95% confidence interval (CI) for the ORR will be computed using the methodology of Clopper-Pearson.

Time frame
Up to 2 years
2

Duration of response

According to Choi, RECIST 1.1, and modified RECIST. Will be analyzed by Kaplan Meier methodology.

Time frame
From the first response and first observation of progressive disease, up to 2 years
3

Renal time to progression

According to Choi, RECIST 1.1, and modified RECIST. Kaplan Meier curves will be presented.

Time frame
Up to 2 years
4

Progression free-survival

According to Choi, RECIST 1.1, and modified RECIST. Kaplan Meier curves will be presented.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jonsson Comprehensive Cancer Center

Lead sponsor

Boston Scientific Corporation

Collaborator

Source ClinicalTrials.gov
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