Stereotactic Ablative Radiation for Oligo-Progression of Urothelial Cancer (SAbR)
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|ClinicalTrials.gov Identifier: NCT04131634|
Recruitment Status : Recruiting
First Posted : October 18, 2019
Last Update Posted : March 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Cancer||Radiation: Stereotactic Ablative Radiation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Stereotactic Ablative Radiation (SAbR) for Urothelial Cancer Patients With Progression While on Anti-PD-1/PD-L1 Immunotherapy|
|Actual Study Start Date :||January 16, 2020|
|Estimated Primary Completion Date :||December 16, 2021|
|Estimated Study Completion Date :||November 16, 2022|
Experimental: SAbR 6 measurable lesions
PD-L1 assessment on biopsy of metastatic site (biopsy will be performed if no prior metastasis sample available)
Radiation: Stereotactic Ablative Radiation
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
- Progression free survival (PFS) at 6 months [ Time Frame: 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.
- The disease control rate [ Time Frame: 6 months ]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).
- The time to next-line systemic therapy [ Time Frame: 6 months ]The time to initiation of next-line systemic therapy following the addition of SAbR to ICI after progression on ICI.
- Overall survival of patients [ Time Frame: 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04131634
|Contact: Sarah Hardee, MSfirstname.lastname@example.org|
|Contact: Sandra Morones, MS||2146458525||Sandra.Morones@UTSouthwestern.edu|
|United States, Texas|
|Dallas, Texas, United States, 75390|
|Contact: Liliana Robles, MS 214-645-8525|
|Principal Investigator:||Aurelie Garant||University of Texas Medical Center|