Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-03-04 @ 9:13 AM
Study NCT ID:
NCT03139318
Status:
TERMINATED
Last Update Posted:
2022-07-20
First Post:
2017-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity
Sponsor:
University of Arkansas
Organization:
Study Overview
Official Title:
Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity
Status:
TERMINATED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to COVID-19 and the resulting administrative issues, it is not feasible to continue the study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to evaluate the toxicity profile of GRID therapy using dose levels of 10Gy, 15 Gy and 20Gy in pediatric osteosarcoma of the extremity.
Detailed Description:
Subjects will receive GRID radiotherapy. GRID radiation therapy is considered a standard radiation therapy method however is not typically used in pediatric osteosarcoma patients. This protocol will evaluate whether or not the use of this therapy will provide benefit to this patient population.
Study Oversight
Has Oversight DMC:
False
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?: