Trials / Recruiting
RecruitingNCT06103669
Locally AblatiVe TherApy in OLigO-pRogressive SOlid TUmorS (VALOROUS)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- University of California, Davis · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ablative local therapy | Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy |
Timeline
- Start date
- 2023-10-05
- Primary completion
- 2025-12-05
- Completion
- 2031-01-05
- First posted
- 2023-10-27
- Last updated
- 2024-12-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06103669. Inclusion in this directory is not an endorsement.