Viewing Study NCT06103682



Ignite Creation Date: 2024-05-06 @ 7:42 PM
Last Modification Date: 2024-10-26 @ 3:12 PM
Study NCT ID: NCT06103682
Status: RECRUITING
Last Update Posted: 2023-10-31
First Post: 2023-10-19

Brief Title: LOcally ABLatIve ThErapy for OligopRogressive Lung And Thoracic MalignanciEs OBLITERATE
Sponsor: University of California Davis
Organization: University of California Davis

Study Overview

Official Title: LOcally ABLatIve ThErapy for OligopRogressive Lung And Thoracic MalignanciEs OBLITERATE
Status: RECRUITING
Status Verified Date: 2023-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: OBLITERATE
Brief 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 andor interventional radiologist

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None