Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416007
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-06
Brief Title:
Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors
Sponsor:
University of Cincinnati
Organization:
University of Cincinnati
Study Overview
Official Title:
A Phase 2 Study of Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The purpose of this research study is to determine if lattice radiation therapy LRT will provide better treatment for bulky large tumors than current standard of care radiotherapy
Detailed Description:
This will be a single-institution single-arm Phase II trial with an anticipated total of 37 patients enrolled Treatment will consist of 5 fractions of lattice radiation therapy delivered every other day The primary endpoints will include the efficacy of lattice therapy as evaluated by ORR CR or PR per RECIST criteria at 60 days 2 months post-treatment and safety Toxicity will be evaluated at day 5 - 2 days day 15 - 5 days day 30 - 5 days and day 60 - 7 days post-completion of lattice therapy This study will also include a translational analysis of the impact of lattice therapy on systemic immune responses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None