Trial Outcomes & Findings for Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity (NCT NCT03139318)

Last Updated: 2022-07-20

Results Overview

The study endpoint is dose-limiting toxicity (DLT), which is defined as a treatment-related AE of Grade 3 or higher.

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

An average of 12 months

Results posted on

2022-07-20

Participant milestones
Measure	GRID Radiotherapy Patients will be treated with GRID Radiotherapy GRID radiotherapy: Patients will be treated with GRID radiotherapy
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity

Baseline characteristics by cohort
Measure	GRID Radiotherapy n=1 Participants Patients will be treated with GRID Radiotherapy GRID radiotherapy: Patients will be treated with GRID radiotherapy
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

Timeframe: An average of 12 months

The study endpoint is dose-limiting toxicity (DLT), which is defined as a treatment-related AE of Grade 3 or higher.

Outcome measures
Measure	GRID Radiotherapy n=1 Participants Patients will be treated with GRID Radiotherapy GRID radiotherapy: Patients will be treated with GRID radiotherapy
Number of Participants With Toxicities Associated With GRID Radiotherapy	1 Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	GRID Radiotherapy n=1 participants at risk Patients will be treated with GRID Radiotherapy GRID radiotherapy: Patients will be treated with GRID radiotherapy
Surgical and medical procedures Surgical wound breakdown (Grade 2)	100.0% 1/1 • Number of events 1 • 90 days (+/- 7 days) post surgery The PI must be notified within 24 hours of learning of any serious adverse events, regardless of attribution, occurring during the study. The IRB must be notified within 10 business days of any unanticipated problems involving risk to subjects or others. All other adverse events, such as those that are expected, or are unlikely or definitely not related to the study participation, are to be reported annually as part of regular IRB continuing review.
Surgical and medical procedures Surgical wound breakdown (Grade 3)	100.0% 1/1 • Number of events 1 • 90 days (+/- 7 days) post surgery The PI must be notified within 24 hours of learning of any serious adverse events, regardless of attribution, occurring during the study. The IRB must be notified within 10 business days of any unanticipated problems involving risk to subjects or others. All other adverse events, such as those that are expected, or are unlikely or definitely not related to the study participation, are to be reported annually as part of regular IRB continuing review.

University of Arkansas for Medical Sciences

Phone: 5016868274