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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
Must not have
Medical comorbidities precluding locally ablative therapies
History of treatment related toxicities that limit or prohibit application of locally ablative therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months from the first day of ablative local therapy
Awards & highlights
No Placebo-Only Group
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot undergo treatments that target specific areas due to my health conditions.
Select...
I have side effects from past treatments that prevent me from getting certain local therapies.
Select...
My brain tumor is growing.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with controlled disease
Secondary study objectives
Median overall survival
Number of participants experiencing grade ≥ 3 adverse events attributable to ablative local therapy
Time to treatment failure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
946 Previous Clinical Trials
4,755,980 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,430 Total Patients Enrolled
Mamta Parikh, MD, MSPrincipal InvestigatorUniversity of California, Davis