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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This phase 2 study tests whether adding treatment to destroy cancer in specific spots helps people stay on their current cancer medicine longer. It is for adults with certain solid tumors whose cancer is growing or newly appearing in no more than 5 spots while most of their cancer stays stable.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have confirmed breast cancer, cancer of the female reproductive organs, head or neck cancer, sarcoma (cancer of bone or soft tissue), or another solid cancer allowed by the study.
  • Sign and date a form agreeing to join the study.
  • Be willing to follow all study steps and be available for the whole study.
  • Be taking cancer medicine that works throughout the body and able to continue it, with a planned break of no more than 30 days for treatment of specific spots.
  • Have had at least one course of medicine for cancer that has spread. The latest course must have helped for at least 3 months before new spots appeared, with most cancer stable and no need to change medicine right away.
  • Have no more than 5 cancer spots that are growing or newly appearing after cancer has spread.
  • Have all growing or new cancer spots judged safe to treat with methods that destroy cancer in specific spots.

Who can't join

  • Have other health problems that make treatment to destroy cancer in specific spots unsafe.
  • Have had side effects from past treatment that limit or prevent treatment to destroy cancer in specific spots.
  • Have cancer spots inside the skull that are growing.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

CA