Status:
TERMINATED
Stereotactic Ablative Radiation for Oligo-Progression of Urothelial Cancer
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Urothelial Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04131634
Start Date
January 16 2020
End Date
June 10 2021
Last Update
June 16 2021
Active Locations (1)
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1
Aurelie Garant
Dallas, Texas, United States, 75390