Combining local therapies with systemic treatment for certain cancers
Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER)
This study is testing if adding local treatments like targeted radiation or ablation can help people with certain types of cancer, such as prostate or kidney cancer, stay on their main treatment longer without needing changes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT06101290 on ClinicalTrials.gov |
What this trial studies
This phase 2 pragmatic study evaluates the effectiveness of adding locally ablative therapies to ongoing systemic therapy for patients with oligo-progressive solid tumors, specifically prostate cancer, urothelial carcinoma, and renal cell carcinoma. The primary goal is to assess disease control at three months, defined as the ability to continue systemic therapy without changes or permanent discontinuation after receiving local ablative treatment. Participants will receive either stereotactic ablative radiotherapy or interventional radiology ablation therapy, based on the discretion of their treating physicians, and will be monitored for up to five years. The study aims to determine the time to treatment failure following the addition of these local therapies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed prostate cancer, urothelial carcinoma, or renal cell carcinoma who are currently on systemic therapy and have shown clinical benefit from their treatment.
Not a fit: Patients who have not responded to systemic therapy or have more than five progressing lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes for patients with specific types of cancer by prolonging the effectiveness of systemic therapies.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in combining local and systemic therapies for cancer treatment, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies: 1. Cohort A: prostate cancer 2. Cohort B: urothelial carcinoma 3. Cohort C: renal cell carcinoma 2. Provision of signed and dated informed consent form. 3. Stated willingness to comply with all study procedures and availability for the duration of the study. 4. Age ≥18 years at time of consent. 5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy. 6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\] 7. ≤ 5 progressing or new metastatic lesions. 8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist. Exclusion Criteria: 1. Medical comorbidities precluding locally ablative therapies. 2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies. 3. Progressing intracranial lesions.
Where this trial is running
Sacramento, California
- University of California, Davis — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Mamta Parikh, MD, MS — University of California, Davis
- Study coordinator: Selina Laqui
- Email: sblaqui@ucdavis.edu
- Phone: 916-734-0565
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.