The purpose of this study is to investigate the use of an MR-guided linear accelerator to treat early stage renal cancer patients, considered inoperable or in patients declining surgerys. The study will collect efficacy, toxicity, and dosimetry data and assess the degree of improvement provided by this treatment technique. The primary objective is to evaluate whether magnetic resonance imaging (MRI)-guided radiation therapy (MRgRT) for primary renal cancer has an improved toxicity profile relative to conventional computed tomography (CT) based radiation therapy, as measured by the frequency of grade 2+ adverse events following MRgRT as per Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
MRI images are obtained before treatment, for adaptive planning, as well as in real-time, to allow for motion monitoring and respiratory gating.
The patients will be treated using an MR-guided approach with adaptive online replanning and respiratory gating using an Elekta Unity MR linac system. Stereotactic Body Radiotherapy (SBRT) will be delivered with a prescription dose of 26Gy in 1 fraction to the PTV\_26 volume as defined by MR imaging.
NYU Langone Health
New York, New York, United States
RECRUITINGNumber of grade 2 or higher toxicity events
Determined as the frequency of grade 2+ adverse events following treatment as per Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Time frame: Up to 12 months after completion of treatment
Change in glomerular filtration rate
Time frame: Baseline, Month 12
Number of treatment related toxicities
This will provide a broader perspective of toxicity by including the Grade 1 toxicities, relative to the primary endpoint.
Time frame: Up to 12 months after completion of treatment
Progression free survival
PFS is defined as the time from initiation of treatment to disease progression or death from any cause.
Time frame: Month 12
Distant metastasis-free survival
Defined as the length of time after treatment that a patient lives without the cancer spreading to distant organs or parts of the body.
Time frame: Month 12
Overall survival
OS is defined as the time from initiation of treatment to death from any cause.
Time frame: Month 12
Number of doses that were planned and delivered
Time frame: Up to 3 months
Number of normal tissue true delivered doses with grade 3+ toxicity at 12 months after completion of MRgRT
Time frame: 12 months after completion of treatment
Rate of cases in which the prescribed isodose line failed to cover 95% of the gross tumor volume (GTV)
Time frame: Up to 3 months
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