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Ablative Therapy for Oligoprogressive Genitourinary Cancers (LAYOVER Trial)
N/A
Recruiting
Led By Mamta Parikh, MD, MS
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≤ 5 progressing or new metastatic lesions
Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies: Cohort A: prostate cancer, Cohort B: urothelial carcinoma, Cohort C: renal cell carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months from the first day of ablative local therapy
Awards & highlights
LAYOVER Trial Summary
This trial studies if adding local therapy to systemic treatment can help treat cancer that is not progressing quickly. Primary outcome is time until treatment stops working.
Who is the study for?
This trial is for adults over 18 with certain genitourinary cancers (prostate, bladder, or kidney) that have spread but are limited to 5 new or worsening spots. They must be on a systemic therapy that's been working for at least 3 months and can continue after local treatment. People can't join if they have health issues preventing local therapy or had bad reactions to such treatments before.Check my eligibility
What is being tested?
The study tests the benefit of adding targeted local therapies to ongoing systemic cancer treatments in patients whose cancer has mostly been controlled but started progressing in up to five areas. The main goal is seeing how long patients can go without their treatment failing after this combination.See study design
What are the potential side effects?
While specific side effects aren't listed here, locally ablative therapies generally may include pain at the treatment site, fatigue, skin changes like redness or blistering, and potential damage to nearby organs depending on where the treatment is aimed.
LAYOVER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have 5 or fewer new or worsening cancer spots.
Select...
I have been diagnosed with prostate, bladder, or kidney cancer.
Select...
I am 18 years old or older.
LAYOVER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months from the first day of ablative local therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months from the first day of ablative local therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with controlled disease
Secondary outcome measures
Median overall survival
Number of participants experiencing grade ≥ 3 adverse events attributable to ablative local therapy
Time to treatment failure
LAYOVER Trial Design
1Treatment groups
Experimental Treatment
Group I: Ablative local therapyExperimental Treatment1 Intervention
Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,369 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,291 Total Patients Enrolled
Mamta Parikh, MD, MSPrincipal InvestigatorUniversity of California, Davis
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are involved with this investigation?
"Affirmative. According to the clinicaltrials.gov, this medical study is currently inviting participants. The trial was launched on October 5th 2023 and was recently modified on October 19th 2023; 150 patients are being recruited from one location."
Answered by AI
Is participation in this trial available at the present time?
"Affirmative. Clinicaltrials.gov reveals that this clinical trial, which was posted on October 5th 2023, is currently enrolling participants. One hundred fifty people must be recruited from 1 medical location."
Answered by AI
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