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

Not Applicable

Recruiting

• Conditions: Head and Neck Cancer; Sarcoma; Other Cancer; Breast Cancer; Oligoprogressive
• Interventions: Device: Ablative local therapy

• Registration Number: NCT06103669
• Lead Sponsor: University of California, Davis

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.

Study Timeline

• Study Start: 2023-10-05
• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-12-05
• Study Completion: 2031-01-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ablative local therapy	Ablative local therapy	Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy

Primary Outcome Measures

Name	Time	Method
Number of participants with controlled disease	3 months from the first day of ablative local therapy	Number of participants with controlled disease 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

Secondary Outcome Measures

Name	Time	Method
Number of participants experiencing grade ≥ 3 adverse events attributable to ablative local therapy	Up to 2 years from the first day of ablative local therapy	Number of participants experiencing grade ≥ 3 adverse events (except for hematologic and electrolyte abnormalities) attributable to ablative local therapy occurring up to 2 years from the first day of ablative local therapy
Median overall survival	Up to 1 year from the first day of ablative local therapy	Median overall survival stratified by primary tumor type
Time to treatment failure	Up to 1 year from the first day of ablative local therapy	Time to treatment failure, defined as time to change in systemic therapy or permanent discontinuation of cancer therapy

Trial Locations

Locations (1)

University of California, Davis; 🇺🇸 Sacramento, California, United States