Locally ablatiVe therApy in oLigO-pRogressive sOlid tUmorS (VALOROUS)
University of California, Davis
Summary
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.
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 a…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies: 1. Cohort A: Breast Malignancy 2. Cohort B: Gynecological Malignancy 3. Cohort C: Head and Neck Malignancies 4. Cohort D: Sarcomas 5. Cohort E: Other solid malignancy specified in the protocol 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 th…
Interventions
- DeviceAblative local therapy
Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy
Location
- University of California, DavisSacramento, California