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

Description

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.

Conditions

Breast Cancer, Oligoprogressive, Head and Neck Cancer, Sarcoma, Other Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Sacramento

University of California, Davis, Sacramento, California, United States, 95817

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Davis,

Xiao Zhao, MD, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

2031-01-05