Back to resultsPhase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity
Primary Purpose
Osteosarcoma in Children, Radiation Toxicity
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GRID radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Osteosarcoma in Children
Eligibility Criteria
Inclusion Criteria:
- History of cytological or histological documentation of non-metastatic extremity osteosarcoma.
- 5-21 years of age.
- Subject is eligible for routine chemotherapy and routine surgery for the treatment of non-metastatic extremity osteosarcoma
- Informed consent is obtained
Exclusion Criteria:
- Females with a positive urine pregnancy test.
- Unable to comply with study procedures
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GRID Radiotherapy
Arm Description
Patients will be treated with GRID Radiotherapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03139318
Brief Title
Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity
Official Title
Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to COVID-19 and the resulting administrative issues, it is not feasible to continue the study.
Study Start Date
July 25, 2017 (Actual)
Primary Completion Date
August 29, 2018 (Actual)
Study Completion Date
August 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma in Children, Radiation Toxicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GRID Radiotherapy
Arm Type
Experimental
Arm Description
Patients will be treated with GRID Radiotherapy
Intervention Type
Radiation
Intervention Name(s)
GRID radiotherapy
Intervention Description
Patients will be treated with GRID radiotherapy
Primary Outcome Measure Information:
Title
Number of Participants With Toxicities Associated With GRID Radiotherapy
Description
The study endpoint is dose-limiting toxicity (DLT), which is defined as a treatment-related AE of Grade 3 or higher.
Time Frame
An average of 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of cytological or histological documentation of non-metastatic extremity osteosarcoma.
5-21 years of age.
Subject is eligible for routine chemotherapy and routine surgery for the treatment of non-metastatic extremity osteosarcoma
Informed consent is obtained
Exclusion Criteria:
Females with a positive urine pregnancy test.
Unable to comply with study procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Harrell, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity
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