Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER)

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Oct 19, 2023

Keywords

ClinConnect Summary

The LAYOVER clinical trial is studying the benefits of combining regular cancer treatments (called systemic therapy) with special local treatments aimed at targeting specific tumors in patients with certain types of advanced cancer, including prostate cancer, urothelial carcinoma, and renal cell carcinoma. The main goal is to see how long patients can continue their current treatment without needing a change after receiving these local therapies.

To be eligible for this trial, participants need to be at least 18 years old and currently receiving systemic therapy for their cancer, with some success in controlling the disease before new tumors appear. They should have no more than five new or worsening tumors that can be treated with local therapies. Participants can expect to continue their regular treatment while also receiving these additional targeted therapies and will be closely monitored throughout the study. It's important for potential participants to discuss their medical history and any other health issues with their doctor to determine if they qualify for this trial.

Gender

ALL

Eligibility 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.