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Trial Title:
Locally ablatiVe therApy in oLigO-pRogressive sOlid tUmorS (VALOROUS)
NCT ID:
NCT06103669
Condition:
Breast Cancer
Oligoprogressive
Head and Neck Cancer
Sarcoma
Other Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Ablative local therapy
Description:
Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation
therapy
Arm group label:
Ablative local therapy
Summary:
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:
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, Davis
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Recruiting
Contact:
Last name:
Selina Laqui
Phone:
916-734-0565
Email:
sblaqui@ucdavis.edu
Investigator:
Last name:
Xiao Zhao, MD
Email:
Principal Investigator
Start date:
October 5, 2023
Completion date:
January 5, 2031
Lead sponsor:
Agency:
University of California, Davis
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of California, Davis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06103669
