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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06103682
Other study ID # UCDCC313
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 5, 2023
Est. completion date January 5, 2031

Study information

Verified date October 2023
Source University of California, Davis
Contact Selina Laqui
Phone 916-734-0565
Email sblaqui@ucdavis.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 5, 2031
Est. primary completion date December 5, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies: 1. Cohort A: Non-small cell cancer 2. Cohort B: Small cell cancer 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 Design


Intervention

Device:
Ablative local therapy
Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy

Locations

Country Name City State
United States University of California, Davis Sacramento California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Davis National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 3 months from the first day of ablative local therapy
Secondary 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 Up to 2 years from the first day of ablative local therapy
Secondary Median overall survival Median overall survival stratified by primary tumor type Up to 1 year from the first day of ablative local therapy
Secondary 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
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