Stereotactic Ablative Radiation for Oligo-Progression of Urothelial Cancer

Urothelial Cancer Clinical Trial

— SAbR  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04131634
• Other study ID #: 2019-1506
• Status: Terminated
• Phase: Phase 2
• Start date: January 16, 2020
• Est. completion date: June 10, 2021

Study information

• Verified date: June 2021
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the benefit of SAbR for oligo-progressive metastatic urothelial cancer.

Description:

Oligo-progressive urothelial cancer with limited disease burden and progression on an anti-PD-1/L1 immune checkpoint inhibitor.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 10, 2021
• Est. primary completion date: December 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must be at least 18-years-old

• ECOG performance status 0-2

• Patients must have pathology-proven metastatic urothelial carcinoma, with tissue sampling of at least the primary tumor. Tissue sampling of each presumed metastatic site is not necessary, provided that the patient already has a confirmed diagnosis of urothelial cancer.

• Patients must be on immune checkpoint inhibitor therapy with radiographic scans to verify oligo-progression of at least one and = 6 sites of disease per RECIST 1.1.

• Any of the currently FDA-approved PD-1/PD-L1 inhibitors are allowed. These include pembrolizumab, nivolumab, atezolizumab, avelumab, and durvalumab.

• At least 1 metastatic lesion must show stable disease, partial response or complete response per RECIST 1.1.

• Patients must be able to understand and willing to sign written informed consent.

• Patients must have acceptable tolerability of ongoing therapy as decided by the treating medical oncologist.

• Patients must have a desire to continue ongoing therapy.

• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.

• A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

• Has not undergone a hysterectomy or bilateral oophorectomy, or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

• Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Exclusion Criteria:

• Inability to receive further immune checkpoint inhibitor therapy

• Anticipated survival of fewer than 12 weeks

• Daily steroid requirement of > 10 mg prednisone or prednisone-equivalent. Steroid replacement therapy for adrenal insufficiency is permitted.

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.

• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Related Conditions & MeSH terms

• Disease Progression
• Urothelial Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Aurelie Garant	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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).	6 months
Secondary	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.	6 months
Secondary	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.	6 months