Actively Recruiting
Locally Ablative Therapy in Oligo-Progressive Genitourinary Tumors (LAYOVER)
Led by University of California, Davis · Updated on 2024-12-18
150
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to assess the clinical benefit of continuing systemic therapy combined with locally ablative therapies for patients with oligo-progressive solid tumors, specifically genitourinary cancers such as prostate cancer, urothelial carcinoma, and renal cell carcinoma. The primary goal is to measure disease control at 3 months, defined as ongoing systemic therapy without changes or permanent discontinuation following local ablative treatment. This is a phase 2 pragmatic study conducted at a single site. Participants will receive locally ablative therapy, which may include stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation, in addition to their current systemic therapy. The specific ablative therapy will be selected by the treating radiation oncologist or interventional radiologist. Participants must be on systemic therapy and able to continue it with no more than a 30-day break to allow for ablative treatment. The study will follow participants for up to 5 years after the first day of ablative local therapy. During the study, participants will be monitored for disease control, adverse events related to ablative therapy, overall survival, and time to treatment failure for up to 1 to 2 years depending on the measure. Researchers will assess disease status at 3 months post-treatment and track any grade 3 or higher adverse events. Follow-up evaluations and clinical assessments will occur regularly to observe the effects and safety of combining systemic therapy with locally ablative treatments.
CONDITIONS
Brief Title
Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have a confirmed diagnosis of one of the following genitourinary cancers: prostate cancer, urothelial carcinoma, or renal cell carcinoma
- Age 18 years or older at the time of consent
- Currently receiving systemic therapy with the ability to continue it with no more than a 30-day break
- At least one line of systemic therapy for metastatic disease with clinical benefit for 3 months or more on the most recent therapy
- Have 5 or fewer progressing or new metastatic lesions
- All progressing or new metastatic lesions can be safely treated with locally ablative therapies
- Willingness to comply with all study procedures and availability for the study duration
- Signed and dated informed consent form
You will not qualify if you...
- Medical conditions that prevent receiving locally ablative therapies
- History of treatment-related toxicities limiting or prohibiting locally ablative therapies
- Presence of progressing intracranial lesions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants receive stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy in addition to continuing their systemic therapy.
Visits as needed per local ablative therapy standards
Duration - Up to 5 years
Participants are followed for safety, disease control, and survival outcomes after ablative local therapy.
Periodic follow-up visits over 5 years
Trial Site Locations
Total: 1 location
1
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
S
Selina Laqui
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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