Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ablative local therapy.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Oligoprogressive, Urothelial Carcinoma, Renal Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.
Detailed description
This is a phase 2 pragmatic study at a single site that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary endpoint is disease control at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy. Participants will receive ablative local therapy per standard practices in addition to their systemic therapy and will be followed for up to 5 years following ablative local therapy. Participants will be assigned stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy per the discretion of treating radiation oncologist and/or interventional radiologist.
Interventions
- Device Ablative local therapy
Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy
Primary outcome measures
- Number of participants with controlled disease [Time frame: 3 months from the first day of ablative local therapy]
Secondary outcome measures (3)
- Number of participants experiencing grade ≥ 3 adverse events attributable to ablative local therapy [Time frame: Up to 2 years from the first day of ablative local therapy]
- Median overall survival [Time frame: Up to 1 year from the first day of ablative local therapy]
- Time to treatment failure [Time frame: Up to 1 year from the first day of ablative local therapy]
Eligibility criteria
Inclusion criteria
- 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
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age ≥18 years at time of consent.
- 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.
- ≥ 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. \[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\]
- ≤ 5 progressing or new metastatic lesions.
- 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
- Medical comorbidities precluding locally ablative therapies.
- History of treatment related toxicities that limit or prohibit application of locally ablative therapies.
- Progressing intracranial lesions.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California, Davis — Sacramento
Identifiers
NCT: NCT06101290 · UCDCC312