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BRIEF TITLE: Stereotactic Ablative Radiation (SAbR) for Urothelial Cancer Patients With Progression While on Anti-PD-1/PD-L1 Immunotherapy

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


  • Org Study ID: 2019-1506
  • Secondary ID:
  • NCT ID: NCT04131634
  • NCT Alias:
  • Sponsor: University of Texas Southwestern Medical Center - Other
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting January 16, 2020 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Progression Free Survival

Primary Outcome 1 - Time Frame: 6 months

Condition:

  • Urothelial Cancer

Eligibility

Criteria:
Inclusion Criteria:

- Patients must be at least 18-years-old

- Patients must have pathology-proven metastatic urothelial carcinoma, with tissue
sampling of at least the primary tumor

- Patients must be on immune checkpoint inhibitor therapy with radiographic scans to
verify oligo-progression

- Women of child-bearing potential and men must agree to use adequate contraception
prior to study entry, for the duration of study participation, and for 90 days
following completion of therapy

Exclusion Criteria:

- Inability to receive further immune checkpoint inhibitor therapy

- Anticipated survival of fewer than 12 weeks

- Steroid replacement therapy for adrenal insufficiency is permitted.
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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: Sarah Hardee, MS

Phone: 2146458525

Email: sarah.hardee@utsouthwestern.edu

Location

Facility Status Contact
Aurelie Garant
Dallas, Texas 75390
United States
Recruiting Liliana Robles, MS
214-645-8525