Clinical trial NCT04131634: Stereotactic Ablative Radiation for Oligo-Progression of Urothelial Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Urothelial Cancer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Progression free survival (PFS) at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: The disease control rate
timeFrame: 6 months
measure: The time to next-line systemic therapy
timeFrame: 6 months
measure: Overall survival of patients
timeFrame: 6 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Aurelie Garant
state: Texas
Study officials:
affiliation: University of Texas Medical Center
name: Aurelie Garant
role: PRINCIPAL_INVESTIGATOR
References: