Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04580836
Status:
WITHDRAWN
Last Update Posted:
2021-12-01
First Post:
2020-09-21
Brief Title:
MRI-Guided Radiation Therapy for the Treatment of Early-Stage Kidney Cancer the MRI-MARK Trial
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
MRI-Guided Stereotactic Body Radiotherapy for the Treatment of Early Stage Kidney Cancer A Single Arm Phase II Clinical Trial MRI-MARK
Status:
WITHDRAWN
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
A study with 0 ACTUAL Enrollment must have Overall Recruitment Status specified as Withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial investigates how well MRI-guided stereotactic body radiation therapy works in treating patients with early-stage kidney cancer Radiation therapy uses high energy radiation to kill tumor cells and shrink tumors Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue This method of radiation delivery is further refined through the incorporation of a MRI into the radiation machine to create a device known as a MRI linear accelerator During treatment with MRI linear accelerator continuous MRI images are obtained to allow for real-time treatment monitoring and the ability to adjust treatment plans if minor deviations in anatomy are noted Giving MRI-guided stereotactic body radiation therapy may help treat patients with early-stage kidney cancer
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate local control following magnetic resonance imaging MRI-guided stereotactic body radiation therapy SBRT for primary kidney cancer as defined by no growth by imaging at 24 months following SBRT
SECONDARY OBJECTIVES
I To estimate preservation of renal function and to determine frequency of grade 3 adverse events following SBRT as per Common Terminology Criteria for Adverse Events CTCAE version 50
II To characterize tumor and treated kidney changes by multiparametric MRI including utility of diffusion and perfusion changes in renal cell carcinoma RCC prior to and after SBRT as biomarkers of treatment response
III To estimate the rate of pathologic complete response as determined by tumor biopsy at 24 months following SBRT
IV To estimate rate of no progression by Response Evaluation Criteria in Solid Tumors RECIST at 24 months less than 20 growth in largest tumor dimension as measured by imaging
V To estimate the rates of overall survival and distant metastasis VI To evaluate economic strain following SBRT for primary kidney cancer VII Compare planned total doses to true total doses delivered to the target and adjacent normal structures to correlate true delivered doses to normal structures to grade 3 toxicity and to determine the rate of cases in which the prescribed isodose line failed to cover 100 of the internal gross tumor volume iGTV
OUTLINE
Patients undergo an MRI scan to check the status and location of the disease including the motion of the tumor during breathing Two weeks after MRI patients undergo SBRT over 1-2 hours on 3 non-consecutive weekdays in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 3 6 12 18 and 24 months then every 6 months thereafter until the end of the study
I To evaluate local control following magnetic resonance imaging MRI-guided stereotactic body radiation therapy SBRT for primary kidney cancer as defined by no growth by imaging at 24 months following SBRT
SECONDARY OBJECTIVES
I To estimate preservation of renal function and to determine frequency of grade 3 adverse events following SBRT as per Common Terminology Criteria for Adverse Events CTCAE version 50
II To characterize tumor and treated kidney changes by multiparametric MRI including utility of diffusion and perfusion changes in renal cell carcinoma RCC prior to and after SBRT as biomarkers of treatment response
III To estimate the rate of pathologic complete response as determined by tumor biopsy at 24 months following SBRT
IV To estimate rate of no progression by Response Evaluation Criteria in Solid Tumors RECIST at 24 months less than 20 growth in largest tumor dimension as measured by imaging
V To estimate the rates of overall survival and distant metastasis VI To evaluate economic strain following SBRT for primary kidney cancer VII Compare planned total doses to true total doses delivered to the target and adjacent normal structures to correlate true delivered doses to normal structures to grade 3 toxicity and to determine the rate of cases in which the prescribed isodose line failed to cover 100 of the internal gross tumor volume iGTV
OUTLINE
Patients undergo an MRI scan to check the status and location of the disease including the motion of the tumor during breathing Two weeks after MRI patients undergo SBRT over 1-2 hours on 3 non-consecutive weekdays in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 3 6 12 18 and 24 months then every 6 months thereafter until the end of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-0168 | OTHER | M D Anderson Cancer Center | None |
| NCI-2020-06739 | REGISTRY | None | None |