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

University of Arkansas1 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteosarcoma in Children Radiation Toxicity

Interventions

GRID radiotherapyRADIATION

Patients will be treated with GRID radiotherapy

Eligibility

Sex: ALLMin age: 5 YearsMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

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.

Time frame: An average of 12 months

Data from ClinicalTrials.gov

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