Ignite Creation Date:
2024-05-06 @ 8:57 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02864615
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2016-08-09
Brief Title:
Safety and Preliminary Efficacy of SBRT in Patients With Metastatic RCC Treated With Targeted or IO Therapy
Sponsor:
Kidney Cancer Research Bureau
Organization:
Kidney Cancer Research Bureau
Study Overview
Official Title:
A Phase 1b Study of Safety and Preliminary Efficacy of Stereotactic Body Radiation Therapy SBRT in Patients With Metastatic Renal Cell Carcinoma Treated With Targeted or Immuno- Therapy Volga Study
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim of this phase 1b study is to evaluate safety and preliminary efficacy of stereotactic body radiation therapy in patients with metastatic renal cell carcinoma treated with VEGFR mTOR or immune checkpoint inhibitors
Detailed Description:
This is prospective phase 1b study
Patients with metastatic RCC receiving targeted or IO therapy VEGFR inhibitor or mTOR inhibitor or checkpoint inhibitors in approved treatment lines and in standard therapeutic regimens with stable diseaseor durable partial response for at least 4 months are enrolled in the study
The initial examination includes CT with contrast where the selected measured 2 metastatic sites stable for at least 4 months but no more than 6 months of targeted therapy increase or decrease in size in the course of targeted therapy should not exceed 10 Metastases have to be located in one organ Allowed location of metastases lungs liver lymph nodes contralateral kidney adrenal gland
Size of selected metastases should not be less than 5 mm and not more than 4 cm
Patients with metastatic RCC receiving targeted or IO therapy VEGFR inhibitor or mTOR inhibitor or checkpoint inhibitors in approved treatment lines and in standard therapeutic regimens with stable diseaseor durable partial response for at least 4 months are enrolled in the study
The initial examination includes CT with contrast where the selected measured 2 metastatic sites stable for at least 4 months but no more than 6 months of targeted therapy increase or decrease in size in the course of targeted therapy should not exceed 10 Metastases have to be located in one organ Allowed location of metastases lungs liver lymph nodes contralateral kidney adrenal gland
Size of selected metastases should not be less than 5 mm and not more than 4 cm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None