NCT03139318

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

July 25, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2018

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

July 12, 2022

Completed
Last Updated

July 20, 2022

Status Verified

June 1, 2022

Enrollment Period

1.1 years

First QC Date

April 25, 2017

Results QC Date

June 16, 2022

Last Update Submit

July 11, 2022

Conditions

Osteosarcoma in ChildrenRadiation Toxicity

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Toxicities Associated With GRID Radiotherapy

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

    An average of 12 months

Study Arms (1)

GRID Radiotherapy

EXPERIMENTAL

Patients will be treated with GRID Radiotherapy

Radiation: GRID radiotherapy

Interventions

GRID radiotherapyRADIATION

Patients will be treated with GRID radiotherapy

GRID Radiotherapy

Eligibility Criteria

Age5 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • History of cytological or histological documentation of non-metastatic extremity osteosarcoma.
  • years of age.
  • Subject is eligible for routine chemotherapy and routine surgery for the treatment of non-metastatic extremity osteosarcoma
  • Informed consent is obtained

You may not qualify if:

  • Females with a positive urine pregnancy test.
  • Unable to comply with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

Title
Beth Scanlan
Organization
University of Arkansas for Medical Sciences
bscanlan@uams.edu
5016868274

Study Officials

  • Leslie Harrell, MD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2017

First Posted

May 3, 2017

Study Start

July 25, 2017

Primary Completion

August 29, 2018

Study Completion

August 29, 2018

Last Updated

July 20, 2022

Results First Posted

July 12, 2022

Record last verified: 2022-06

Locations

US(1)