A Study of Ablative Therapy in People with Progressive Solid Tumors (VALOROUS)

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a study on Breast Cancer Oligoprogressive Head and Neck Cancer Sarcoma Cancer, General Solid Tumor Head and Neck Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California
Dates
study started
study ends around
Principal Investigator
by Xiao Zhao, MD

Description

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.

Official Title

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

Details

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.

Keywords

Breast Cancer, Oligoprogressive, Head and Neck Cancer, Sarcoma, Other Cancer, Breast Neoplasms, Head and Neck Neoplasms, Ablative local therapy

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Location

  • University of California, Davis accepting new patients
    Sacramento California 95817 United States

Lead Scientist at UC Davis

  • Xiao Zhao, MD
    Assistant Professor of Clinical, MED: Radiation-Oncology, School of Medicine. Authored (or co-authored) 9 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
Links
Sign up for this study
ID
NCT06103669
Study Type
Interventional
Participants
Expecting 250 study participants
Last Updated
Contact us about this trial