Locally ablatiVe therApy in oLigO-pRogressive sOlid tUmorS (VALOROUS)

Breast Cancer Clinical Trial

— VALOROUS  

Official title:

Locally ablatiVe therApy in oLigO-pRogressive sOlid tUmorS (VALOROUS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06103669
• Other study ID #: UCDCC314
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2023
• Est. completion date: January 5, 2031

Study information

• Verified date: October 2023
• Source: University of California, Davis
• Contact: Selina Laqui
• Phone: 916-734-0565
• Email: sblaqui[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 5, 2031
• Est. primary completion date: December 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Oligoprogressive
• Other Cancer
• Sarcoma

Intervention

Device:
• Ablative local therapy
Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy

Locations

Country	Name	City	State
United States	University of California, Davis	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease control	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	3 months from the first day of ablative local therapy
Secondary	Grade = 3 adverse events	Number of participants experiencing grade = 3 adverse events (except for hematologic and electrolyte abnormalities) attributable to ablative local therapy	Up to 2 years from the first day of ablative local therapy
Secondary	Median overall survival	Median overall survival stratified by primary tumor type	Up to 1 year from the first day of ablative local therapy
Secondary	Time to treatment failure	Time to treatment failure, defined as time to change in systemic therapy or permanent discontinuation of cancer therapy	Up to 1 year from the first day of ablative local therapy