Combining local ablative therapy with ongoing systemic treatment for certain cancers

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

This study is testing whether adding local treatments to ongoing cancer therapy can help people with certain solid tumors live longer without their disease getting worse.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, Davis (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Sacramento, California)
• Trial ID: NCT06103669 on ClinicalTrials.gov

What this trial studies

This phase 2 pragmatic study evaluates the benefits of continuing systemic therapy while adding locally ablative therapies for patients with oligo-progressive solid tumors. The primary goal is to measure the time to treatment failure after receiving local ablative therapy, with disease control assessed at three months. Participants will receive either stereotactic ablative radiotherapy or interventional radiology ablation therapy, depending on the treating physician's discretion. The study will follow participants for up to five years to monitor outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed breast, gynecological, head and neck malignancies, sarcomas, or other specified solid tumors who are currently on systemic therapy.

Not a fit: Patients who are not currently on systemic therapy or those with rapidly progressing disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment effectiveness and prolong the duration of systemic therapy for patients with specific solid tumors.

How similar studies have performed: Other studies have shown promising results with similar approaches, suggesting potential for success in this trial.

Eligibility criteria

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 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.

Where this trial is running

Sacramento, California

• University of California, Davis — Sacramento, California, United States (Recruiting)

Study contacts

• Principal investigator: Xiao Zhao, MD — University of California, Davis
• Study coordinator: Selina Laqui

Conditions Breast Cancer; Oligoprogressive; Head and Neck Cancer; Sarcoma; Other Cancer