Stereotactic Ablative Radiation for Oligo-Progression of Urothelial Cancer

Stopped early · Phase 2

Conditions studied: Urothelial Cancer

In brief

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

Key facts

Study ID

NCT04131634

Run by

University of Texas Southwestern Medical Center

People needed

2

Starts

2020-01-16

Expected to finish

2021-06-10

Last updated by the study team

2021-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Aurelie Garant — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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