RecruitingNot ApplicableNCT06103669

Locally AblatiVe TherApy in OLigO-pRogressive SOlid TUmorS (VALOROUS)

Sponsor

University of California, Davis

Enrollment

250 participants

Start Date

Oct 5, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Sarcoma Head and Neck Cancer Oligoprogressive Other Cancer

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria13

Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies:
Cohort A: Breast Malignancy
Cohort B: Gynecological Malignancy
Cohort C: Head and Neck Malignancies
Cohort D: Sarcomas
Cohort E: Other solid malignancy specified in the protocol
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 Criteria3

Medical comorbidities precluding locally ablative therapies.
History of treatment related toxicities that limit or prohibit application of locally ablative therapies.
Progressing intracranial lesions.