To evaluate the benefit of SAbR for oligo-progressive metastatic urothelial cancer.
Oligo-progressive urothelial cancer with limited disease burden and progression on an anti-PD-1/L1 immune checkpoint inhibitor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
A stereotactic relocalization system that relies upon stereoscopic radiographs, implanted fiducials, or near real-time CT based verification will be used.Investigators will have the discretion to choose from biologically equivalent dose levels using 1, 3 or 5 fractions. All active lesions need to be addressed by local therapy
Aurelie Garant
Dallas, Texas, United States
Progression free survival (PFS) at 6 months
Progression free survival (PFS) at 6 months in the patients for whom SAbR is added to the ICI after progression on ICI. PFS will be defined as the combination of progressive disease from SAbR start date and death from any cause.
Time frame: 6 months
The disease control rate
The disease control rate in patients for whom SAbR is added to ICI after progression on ICI. DCR will be assessed per RECIST 1.1 criteria and defined as the combination of: Complete Response (CR), Partial Response (PR), or Stable Disease (SD).
Time frame: 6 months
The time to next-line systemic therapy
The time to initiation of next-line systemic therapy following the addition of SAbR to ICI after progression on ICI.
Time frame: 6 months
Overall survival of patients
The overall survival of patients since progression on ICI or at the study registration. Overall survival (OS) will be defined using the interval between enrollment and death from any cause.
Time frame: 6 months
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