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Stereotactic Ablative Radiation for Oligo-Progression of Urothelial Cancer (SAbR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04131634
Recruitment Status : Recruiting
First Posted : October 18, 2019
Last Update Posted : March 9, 2021
Information provided by (Responsible Party):
Aurelie Garant, University of Texas Southwestern Medical Center

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

Condition or disease Intervention/treatment Phase
Urothelial Cancer Radiation: Stereotactic Ablative Radiation Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04131634

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Contact: Sarah Hardee, MS 2146458525
Contact: Sandra Morones, MS 2146458525

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United States, Texas
Aurelie Garant Recruiting
Dallas, Texas, United States, 75390
Contact: Liliana Robles, MS    214-645-8525      
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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Principal Investigator: Aurelie Garant University of Texas Medical Center
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Responsible Party: Aurelie Garant, Associate Professor of Medicine, University of Texas Southwestern Medical Center Identifier: NCT04131634    
Other Study ID Numbers: 2019-1506
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease Progression
Disease Attributes
Pathologic Processes