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NCT03139318 Clinical Trial

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

Radiation Toxicity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03139318
Other study ID # 205993
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 25, 2017
Est. completion date August 29, 2018

Study information
Verified date June 2022
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date August 29, 2018
Est. primary completion date August 29, 2018
Accepts healthy volunteers No
Gender All
Age group 5 Years to 21 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• GRID radiotherapy
Patients will be treated with GRID radiotherapy

Locations
Country Name City State
United States University of Arkansas for Medical Sciences Little Rock Arkansas

Sponsors (1)
Lead Sponsor Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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