## Protocol Section
### Identification Module
**NCT ID:** NCT06432036

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

**Official Title:** RENEGADE: Radioembolization for Early Stage Renal Cell Carcinoma: An Open-Label, Prospective, Multi-Center, Phase 1/2 Safety Trial

#### Organization Study ID Info
**ID:** 23-001261
#### Organization
**Class:** OTHER
**Full Name:** Jonsson Comprehensive Cancer Center
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2024-03516
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2027-06

**Type:** ESTIMATED

#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2025-01-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Boston Scientific Corporation

#### Lead Sponsor

**Class:** OTHER

**Name:** Jonsson Comprehensive Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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.

**Detailed Description:** PRIMARY OBJECTIVE:

I. To assess safety and toxicity of Yttrium-90 radioembolization for renal cell carcinoma (RCC).

SECONDARY OBJECTIVES:

I. To assess tumor response and duration of response, based on Choi, Response Evaluation Criteria in Solid Tumors (RECIST), and modified RECIST criteria.

II. To assess time to disease progression. III. To assess progression free survival and overall survival. IV. To assess stability of renal function via glomerular filtration rate (GFR) and cystatin-C.

V. To describe the difference in quality of life before and after treatment using Eastern Cooperative Oncology Group (ECOG) performance status and RCC-specific Quality of Life (QoL) questionnaire.

OUTLINE:

Patients undergo radioembolization with yttrium Y 90 glass microspheres (TheraSphere) given intra-arterially. Patients undergo angiogram during screening, single proton emission computed tomography (SPECT) scan on study and computed tomography (CT) scan and blood sample collection throughout the study.

After completion of study treatment, patients are followed up at 1 day, 1 week, and then monthly for 24 months.

### Conditions Module

**Conditions:**

- Stage I Renal Cell Cancer

- Stage II Renal Cell Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 25

**Type:** ESTIMATED

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients undergo radioembolization with TheraSphere given intra-arterially. Patients undergo angiogram during screening, SPECT scan on study and CT scan and blood sample collection throughout the study.

**Intervention Names:**

- Procedure: Angiogram

- Procedure: Biospecimen Collection

- Procedure: Computed Tomography

- Radiation: Radioembolization

- Procedure: Single Photon Emission Computed Tomography

- Other: Survey Administration

- Radiation: Yttrium Y 90 Glass Microspheres

**Label:** Treatment (radioembolization, TheraSphere)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment (radioembolization, TheraSphere)

**Description:** Undergo angiogram

**Name:** Angiogram

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Treatment (radioembolization, TheraSphere)

**Description:** Undergo blood sample collection

**Name:** Biospecimen Collection

**Other Names:**

- Biological Sample Collection

- Biospecimen Collected

- Specimen Collection

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- Treatment (radioembolization, TheraSphere)

**Description:** Undergo CT scan

**Name:** Computed Tomography

**Other Names:**

- CAT

- CAT Scan

- Computed Axial Tomography

- Computerized Axial Tomography

- Computerized axial tomography (procedure)

- Computerized Tomography

- Computerized Tomography (CT) scan

- CT

- CT Scan

- tomography

**Type:** PROCEDURE

#### Intervention 4

**Arm Group Labels:**

- Treatment (radioembolization, TheraSphere)

**Description:** Undergo radioembolization

**Name:** Radioembolization

**Other Names:**

- intra-arterial brachytherapy

**Type:** RADIATION

#### Intervention 5

**Arm Group Labels:**

- Treatment (radioembolization, TheraSphere)

**Description:** Undergo SPECT

**Name:** Single Photon Emission Computed Tomography

**Other Names:**

- Medical Imaging, Single Photon Emission Computed Tomography

- Single Photon Emission Tomography

- Single-Photon Emission Computed

- single-photon emission computed tomography

- SPECT

- SPECT imaging

- SPECT SCAN

- SPET

- ST

- tomography, emission computed, single photon

- Tomography, Emission-Computed, Single-Photon

**Type:** PROCEDURE

#### Intervention 6

**Arm Group Labels:**

- Treatment (radioembolization, TheraSphere)

**Description:** Ancillary study

**Name:** Survey Administration

**Type:** OTHER

#### Intervention 7

**Arm Group Labels:**

- Treatment (radioembolization, TheraSphere)

**Description:** Given intra-arterially

**Name:** Yttrium Y 90 Glass Microspheres

**Other Names:**

- TheraSphere

- Y-90 Therasphere

**Type:** RADIATION

### Outcomes Module

#### Primary Outcomes

**Measure:** Number of treatment related adverse events

**Time Frame:** Up to 2 years

**Measure:** Number of serious adverse events

**Time Frame:** Up to 2 years

#### Secondary Outcomes

**Description:** 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.

**Measure:** Overall response rate (ORR)

**Time Frame:** Up to 2 years

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

**Measure:** Duration of response

**Time Frame:** From the first response and first observation of progressive disease, up to 2 years

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

**Measure:** Renal time to progression

**Time Frame:** Up to 2 years

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

**Measure:** Progression free-survival

**Time Frame:** Up to 2 years

**Description:** Kaplan Meier curves will be presented.

**Measure:** Overall survival

**Time Frame:** Up to 2 years

**Description:** Measured by glomerular filtration rate (GFR), creatinine, and cystatin-C.

**Measure:** Change in renal function

**Time Frame:** Up to 2 years

**Description:** Will be summarized as counts and percentage. The corresponding 95% CIs will be computed using Clopper-Pearson.

**Measure:** Proportion of patients receiving subsequent treatment for RCC after study treatment

**Time Frame:** Up to 2 years

**Description:** Will be summarized using descriptive summaries.

**Measure:** Type of subsequent RCC treatment received after study treatment

**Time Frame:** Up to 2 years

**Description:** Will be summarized as counts and percentage. The corresponding 95% CIs will be computed using Clopper-Pearson.

**Measure:** Proportion of patients to undergo curative therapy

**Time Frame:** Up to 2 years

**Description:** Will be summarized using descriptive summaries.

**Measure:** Time to subsequent RCC treatment (local or systemic therapy)

**Time Frame:** Up to 2 years

**Description:** Correlation between tumoral absorbed dose (measured in Gy based on SPECT-CT) and safety (measured by incidence of Grade 3/4 treatment-related adverse events) and efficacy (measured by partial and complete response using Choi/mRECIST/RECIST criteria on follow up cross sectional imaging)

**Measure:** Correlation between tumoral absorbed dose, with efficacy and safety

**Time Frame:** Up to 2 years

**Description:** Correlation between normal tissue absorbed dose (measured in Gy based on SPECT-CT) and safety (measured by incidence of Grade 3/4 treatment-related adverse events) and efficacy (measured by partial and complete response using Choi/mRECIST/RECIST criteria on follow up cross sectional imaging)

**Measure:** Correlation between normal tissue absorbed dose, with efficacy and safety

**Time Frame:** Up to 2 years

**Description:** The scale is Eastern Cooperative Oncology Group (ECOG). Scale is 1 to 5, with 5 being the worst outcome.

**Measure:** Change in Eastern Cooperative Oncology Group score

**Time Frame:** Up to 2 years

**Description:** Change in overall quality of life based on patient-reported outcomes

**Measure:** Change in quality of life as measured by the SF-36 (QualityMetrics) Quality of Life survey

**Time Frame:** Up to 2 years

**Measure:** Percentage of subjects with absorbed Y90 dose within range (+/- 20%) of planned dose

**Time Frame:** Up to 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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
* Clinical stage of RCC: T1 or T2a, Cancer stage (N0M0)
* 1-2 solid (\> 80% solid) target lesions
* Patient not an ideal candidate for partial nephrectomy or thermal ablation at the time of study entry, based on the decision of the institution's multidisciplinary tumor board. Contraindications for partial nephrectomy include inability to potentially partially resect the kidney, high risk of adverse events due to medical comorbidities, or potential high risk of adverse events due to general anesthesia. Contraindications to thermal ablation include potential inability to technically place ablation probes into the tumor, central tumors which risk thermal injury to the renal collecting system
* Patient not considered a candidate for long-term active surveillance due to oncologic risk due to tumor growth and/or tumor size
* Patient not considered ideal candidates for radical nephrectomy due to surgical comorbidity and/or development of adverse health outcomes
* Measurable tumor by RECIST 1.1 criteria
* Absence of bilateral renal tumors
* Negative serum pregnancy test in females of child-bearing potential; patients who are breast-feeding cannot participate in this trial
* Hemoglobin ≥ 9.0 g/dL
* Absolute neutrophil count ≥ 1.5 x 10\^9/L
* Absolute lymphocyte count ≥ 1.0 x 10\^9/L
* Platelet count ≥ 75 x 10\^9/L
* Glomerular filtration rate (GFR) ≥ 45 mL/min/1.73 m\^2
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
* Screening mapping angiogram demonstrates successful localization of tumor(s), where catheter placement location(s) would allow Y90 to distribute in the intended treatment area, without venous shunting

Exclusion Criteria:

* 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 m\^2
* Screening angiography demonstrates renal venous shunting of iodinated contrast that is immediately visible upon arterial injection
* Extra-renal metastases, including patients with abdominal lymph nodes \>1.5 cm in shorter axis, or with lung nodules (single lesion, \>1 cm, or multiple smaller lesions with a total diameter \>2 cm)
* Brain metastases, leptomeningeal carcinomatosis or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry
* Evidence of any tumor invasion into the renal vein, renal artery, or renal collecting system
* Any prior radiation therapy to the abdomen, including localized radiation therapy to the index tumor
* Concurrent treatment for RCC or treatment in the last 6 months in another clinical study, unless it is an observational study (non-interventional) or during a non-interventional follow-up stage of an interventional study, or prior randomization to this study
* History of active primary/acquired immunodeficiency
* Presence of renal ureteral stent in the treatment kidney at any time
* History of malignancy, other than RCC, within three years, with the exception of adequately treatment carcinoma in situ of the cervix, early squamous cell carcinoma or basal cell carcinoma of the skin, localized prostate cancer, ductal carcinoma in situ, or low-grade endometrial carcinoma with no myometrial invasion (negligible risk of metastases or death 5-year overall survival \[OS\] rate \> 90%)
* Major surgical procedure (as defined by the Investigator) within 28 days prior to enrollment
* A history of severe allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
* Active infection
* Female patients who are pregnant or breastfeeding or female patients of reproductive potential who are not willing to employ effective birth control from screening to 6 months after treatment
* Unstable chronic disease or evidence of any disease or condition that would place the patient at undue risk and preclude safe use of Y90 microspheres, including but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent
* History of pulmonary insufficiency, measured by oxygen saturation of less than 90%
* Solitary kidney
* Patient not able to follow the study protocol requirements

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** AMMian@mednet.ucla.edu

**Name:** Arshia Mian

**Phone:** 310-906-6028

**Role:** CONTACT

**Contact 2:**

**Email:** schaabane@mednet.ucla.edu

**Name:** Saima Chaabane

**Phone:** (310)794-8995

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Los Angeles

**Contacts:**

***Contact 1:***

- **Email:** AMMian@mednet.ucla.edu

- **Name:** Arshia A. Mian

- **Phone:** 310-906-6028

- **Role:** CONTACT

***Contact 2:***

- **Email:** schaabane@mednet.ucla.edu

- **Name:** Saima Chaabane

- **Phone:** (310)794-8995

- **Role:** CONTACT

***Contact 3:***

- **Name:** Siddharth A. Padia, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** UCLA / Jonsson Comprehensive Cancer Center

**State:** California

**Zip:** 90095

#### Overall Officials

**Official 1:**

**Affiliation:** UCLA / Jonsson Comprehensive Cancer Center

**Name:** Siddharth A Padia

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000007680

- Term: Kidney Neoplasms

- ID: D000014571

- Term: Urologic Neoplasms

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5548

- Name: Carcinoma, Renal Cell

- Relevance: HIGH

- As Found: Renal Cell Cancer

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M10703

- Name: Kidney Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17320

- Name: Urologic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4906

- Name: Renal Cell Carcinoma

- Relevance: HIGH

- As Found: Renal Cell Cancer

- ID: T1341

- Name: Clear Cell Renal Cell Carcinoma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002292

- Term: Carcinoma, Renal Cell

### Misc Info Module

- Version Holder: 2024-05-31
