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

ConditionsBreast CancerOligoprogressiveHead and Neck CancerSarcomaOther Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cohort A: Breast Malignancy

Cohort B: Gynecological Malignancy

Cohort C: Head and Neck Malignancies

Cohort D: Sarcomas

Disqualifiers

Medical comorbidities precluding locally ablative therapies.

History of treatment related toxicities that limit or prohibit application of locally ablative therapies.

Progressing intracranial lesions.

Trial design

Design model

Single group

Treatments tested in this trial

  • Ablative local therapy

    Device

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

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: Ablative local therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with controlled disease

Number of participants with controlled disease 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

Time frame
3 months from the first day of ablative local therapy

Secondary outcomes

1

Number of participants experiencing grade ≥ 3 adverse events attributable to ablative local therapy

Number of participants experiencing grade ≥ 3 adverse events (except for hematologic and electrolyte abnormalities) attributable to ablative local therapy occurring up to 2 years from the first day of ablative local therapy

Time frame
Up to 2 years from the first day of ablative local therapy
2

Median overall survival

Median overall survival stratified by primary tumor type

Time frame
Up to 1 year from the first day of ablative local therapy
3

Time to treatment failure

Time to treatment failure, defined as time to change in systemic therapy or permanent discontinuation of cancer therapy

Time frame
Up to 1 year from the first day of ablative local therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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