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

Purpose

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.

Conditions

  • Osteosarcoma in Children
  • Radiation Toxicity

Eligibility

Eligible Ages
Between 5 Years and 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
GRID Radiotherapy 		Patients will be treated with GRID Radiotherapy
  • Radiation: GRID radiotherapy
    Patients will be treated with GRID radiotherapy

Recruiting Locations

More Details

NCT ID
NCT03139318
Status
Terminated
Sponsor
University of Arkansas

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.