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Procedure
Ablative Therapy for Oligoprogressive Cancer (VALOROUS Trial)
N/A
Recruiting
Led By Xiao Zhao, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years at time of consent.
≤ 5 progressing or new metastatic lesions.
Must not have
History of treatment related toxicities that limit or prohibit application of locally ablative therapies.
Progressing intracranial lesions.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months from the first day of ablative local therapy
Awards & highlights
No Placebo-Only Group
Summary
This trial studies the effectiveness of adding localized treatments to systemic therapy for solid tumors that have not spread widely. The results will measure how long treatment lasts.
Who is the study for?
Adults over 18 with certain cancers (like breast, gynecological, head and neck, sarcomas) who have up to 5 new or worsening metastatic lesions. They must be on systemic therapy they can continue post-treatment and have seen benefits from it for at least 3 months. Not eligible if they have progressing brain tumors or health issues that rule out local therapies.
What is being tested?
The VALOROUS trial is testing whether adding local ablative treatments (like radiation) to ongoing systemic cancer therapy helps control the disease better in patients whose cancer has started to progress again but only in a limited number of spots.
What are the potential side effects?
While specific side effects are not listed here, generally, local ablative therapies like radiation may cause skin irritation, fatigue, mild pain or discomfort at the treatment site. The exact side effects depend on the area being treated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have 5 or fewer new or growing cancer spots.
Select...
My cancer is confirmed to be in the urinary-genital area.
Select...
I have cancer in my head or neck.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have side effects from past treatments that prevent me from getting certain local therapies.
Select...
My brain tumor is getting worse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months from the first day of ablative local therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months from the first day of ablative local therapy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disease control
Secondary study objectives
Grade ≥ 3 adverse events
Median overall survival
Time to treatment failure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ablative local therapyExperimental Treatment1 Intervention
Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
946 Previous Clinical Trials
4,755,888 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,111,843 Total Patients Enrolled
Xiao Zhao, MDPrincipal InvestigatorUniversity of California, Davis