- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06101290
Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER) (LAYOVER)
November 28, 2023 updated by: Mamta Parikh, University of California, Davis
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Selina Laqui
- Phone Number: 916-734-0565
- Email: sblaqui@ucdavis.edu
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- Recruiting
- University of California, Davis
-
Contact:
- Selina Laqui
- Phone Number: 916-734-0565
- Email: sblaqui@ucdavis.edu
-
Principal Investigator:
- Mamta Parikh, MD, MS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies:
- Cohort A: prostate cancer
- Cohort B: urothelial carcinoma
- Cohort C: renal cell carcinoma
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ablative local therapy
Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy
|
Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with controlled disease
Time Frame: 3 months from the first day of ablative local therapy
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median overall survival
Time Frame: Up to 1 year from the first day of ablative local therapy
|
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 Frame: Up to 1 year from the first day of ablative local therapy
|
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
|
Number of participants experiencing grade ≥ 3 adverse events attributable to ablative local therapy
Time Frame: Up to 2 years from the first day of 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mamta Parikh, MD, MS, University of California, Davis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 5, 2023
Primary Completion (Estimated)
December 5, 2025
Study Completion (Estimated)
January 5, 2031
Study Registration Dates
First Submitted
October 19, 2023
First Submitted That Met QC Criteria
October 19, 2023
First Posted (Actual)
October 26, 2023
Study Record Updates
Last Update Posted (Estimated)
December 4, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma, Renal Cell
- Carcinoma
Other Study ID Numbers
- UCDCC312
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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