Trial Title:
Yttrium-90 (Y90) Radioembolization for the Treatment of Early Stage Renal Cell Carcinoma, The RENEGADE Trial
NCT ID:
NCT06432036
Condition:
Stage I Renal Cell Cancer
Stage II Renal Cell Cancer
Conditions: Official terms:
Carcinoma, Renal Cell
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Angiogram
Description:
Undergo angiogram
Arm group label:
Treatment (radioembolization, TheraSphere)
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (radioembolization, TheraSphere)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT scan
Arm group label:
Treatment (radioembolization, TheraSphere)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Radiation
Intervention name:
Radioembolization
Description:
Undergo radioembolization
Arm group label:
Treatment (radioembolization, TheraSphere)
Other name:
intra-arterial brachytherapy
Intervention type:
Procedure
Intervention name:
Single Photon Emission Computed Tomography
Description:
Undergo SPECT
Arm group label:
Treatment (radioembolization, TheraSphere)
Other name:
Medical Imaging, Single Photon Emission Computed Tomography
Other name:
Single Photon Emission Tomography
Other name:
Single-Photon Emission Computed
Other name:
single-photon emission computed tomography
Other name:
SPECT
Other name:
SPECT imaging
Other name:
SPECT SCAN
Other name:
SPET
Other name:
ST
Other name:
tomography, emission computed, single photon
Other name:
Tomography, Emission-Computed, Single-Photon
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary study
Arm group label:
Treatment (radioembolization, TheraSphere)
Intervention type:
Radiation
Intervention name:
Yttrium Y 90 Glass Microspheres
Description:
Given intra-arterially
Arm group label:
Treatment (radioembolization, TheraSphere)
Other name:
TheraSphere
Other name:
Y-90 Therasphere
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA / Jonsson Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Contact:
Last name:
Arshia A. Mian
Phone:
310-906-6028
Email:
AMMian@mednet.ucla.edu
Contact backup:
Last name:
Saima Chaabane
Phone:
(310)794-8995
Email:
schaabane@mednet.ucla.edu
Investigator:
Last name:
Siddharth A. Padia, MD
Email:
Principal Investigator
Start date:
January 1, 2025
Completion date:
June 2027
Lead sponsor:
Agency:
Jonsson Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
Boston Scientific Corporation
Agency class:
Industry
Source:
Jonsson Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06432036
