Clinical trial NCT06103669: Locally AblatiVe TherApy in OLigO-pRogressive SOlid TUmorS (VALOROUS)
Official title: Locally AblatiVe TherApy in OLigO-pRogressive SOlid TUmorS (VALOROUS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Oligoprogressive
Head and Neck Cancer
Sarcoma
Other Cancer
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-10-27
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Number of participants with controlled disease
timeFrame: 3 months from the first day of ablative local therapy
Secondary outcomes:
measure: Number of participants experiencing grade ≥ 3 adverse events attributable to ablative local therapy
timeFrame: Up to 2 years from the first day of ablative local therapy
measure: Median overall survival
timeFrame: Up to 1 year from the first day of ablative local therapy
measure: Time to treatment failure
timeFrame: Up to 1 year from the first day of ablative local therapy
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Xiao Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References: