Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432036
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-10
Brief Title:
Yttrium-90 Y90 Radioembolization for the Treatment of Early Stage Renal Cell Carcinoma The RENEGADE Trial
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
RENEGADE Radioembolization for Early Stage Renal Cell Carcinoma An Open-Label Prospective Multi-Center Phase 12 Safety Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03516 | REGISTRY | CTRP Clinical Trial Reporting Program | None |