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Brief Title: Stereotactic Ablative Radiation for Oligo-Progression of Urothelial Cancer

A Phase II Trial of Stereotactic Ablative Radiation (SAbR) for Urothelial Cancer Patients With Progression While on Anti-PD-1/PD-L1 Immunotherapy

INTRODUCTION

  • Org Study ID: 2019-1506
  • Secondary ID: N/A
  • NTC ID: NCT04131634
  • Sponsor: University of Texas Southwestern Medical Center

BRIEF SUMMARY

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

DETAILED DESCRIPTION

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

  • Overall Status
    Terminated
  • Start Date
    January 16, 2020
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Progression free survival (PFS) at 6 months

Primary Outcome 1 - Timeframe: 6 months

CONDITION

  • Urothelial Cancer

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Aurelie Garant

Role: Principal Investigator

Affiliation: University of Texas Medical Center

Overall Contact

Name: Aurelie Garant

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact