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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Device: Ablative local therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies: Cohort A: Breast Malignancy Cohort B: Gynecological Malignancy Cohort C: Head and Neck Malignancies Cohort D: Sarcomas Cohort E: Other solid malignancy specified in the protocol Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study. Age ≥18 years at time of consent. 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. ≥ 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] ≤ 5 progressing or new metastatic lesions. 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: Medical comorbidities precluding locally ablative therapies. History of treatment related toxicities that limit or prohibit application of locally ablative therapies. Progressing intracranial lesions.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ablative local therapy<br>Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy | Device: Ablative local therapy<br>* Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control | 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 | 3 months from the first day of ablative local therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade ≥ 3 adverse events | Number of participants experiencing grade ≥ 3 adverse events (except for hematologic and electrolyte abnormalities) attributable to ablative local therapy | Up to 2 years from the first day of ablative local therapy | 
| Median overall survival | Median overall survival stratified by primary tumor type | Up to 1 year from the first day of ablative local therapy | 
| Time to treatment failure | Time to treatment failure, defined as time to change in systemic therapy or permanent discontinuation of cancer therapy | Up to 1 year from the first day of ablative local therapy |