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

Sponsor
University of California, Davis (Other)
Overall Status
Recruiting
CT.gov ID
NCT06103669
Collaborator
National Cancer Institute (NCI) (NIH)
250
1
1
87
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ablative local therapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Locally ablatiVe therApy in oLigO-pRogressive sOlid tUmorS (VALOROUS)
Actual Study Start Date :
Oct 5, 2023
Anticipated Primary Completion Date :
Dec 5, 2025
Anticipated Study Completion Date :
Jan 5, 2031

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ablative local therapy

Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy

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

Outcome Measures

Primary Outcome Measures

  1. Disease control [3 months from the first day of ablative local therapy]

    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

Secondary Outcome Measures

  1. Grade ≥ 3 adverse events [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

  2. Median overall survival [Up to 1 year from the first day of ablative local therapy]

    Median overall survival stratified by primary tumor type

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies:

  2. Cohort A: Breast Malignancy

  3. Cohort B: Gynecological Malignancy

  4. Cohort C: Head and Neck Malignancies

  5. Cohort D: Sarcomas

  6. Cohort E: Other solid malignancy specified in the protocol

  7. Provision of signed and dated informed consent form.

  8. Stated willingness to comply with all study procedures and availability for the duration of the study.

  9. Age ≥18 years at time of consent.

  10. 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.

  11. ≥ 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]

  12. ≤ 5 progressing or new metastatic lesions.

  13. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, Davis Sacramento California United States 95817

Sponsors and Collaborators

  • University of California, Davis
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Xiao Zhao, MD, University of California, Davis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT06103669
Other Study ID Numbers:
  • UCDCC314
First Posted:
Oct 27, 2023
Last Update Posted:
Oct 27, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2023