Stereotactic Ablative Radiation for Oligo-Progression of Urothelial Cancer

NCT04131634 | Terminated Phase 2

• 1 other identifier: 2019-1506
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urothelial Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The disease control rate

  6 months

• The time to next-line systemic therapy

  6 months

• Overall survival of patients

  6 months

Study Arms (1)

SAbR 6 measurable lesions

EXPERIMENTAL

PD-L1 assessment on biopsy of metastatic site (biopsy will be performed if no prior metastasis sample available)

Radiation: Stereotactic Ablative Radiation

Interventions

Stereotactic Ablative Radiation 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

SAbR 6 measurable lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Aurelie Garant

Dallas, Texas, 75390, United States

Location

Study Officials

• Aurelie Garant

  University of Texas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: January 16, 2020
• Primary Completion: December 17, 2020
• Study Completion: June 10, 2021
• Last Updated: June 16, 2021

Record last verified: 2021-06

Locations

US (1)