Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity
Not Applicable
Terminated
- Conditions
- Osteosarcoma in ChildrenRadiation Toxicity
- Interventions
- Radiation: GRID radiotherapy
- Registration Number
- NCT03139318
- Lead Sponsor
- University of Arkansas
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description GRID Radiotherapy GRID radiotherapy Patients will be treated with GRID Radiotherapy
- Primary Outcome Measures
Name Time Method Number of Participants With Toxicities Associated With GRID Radiotherapy An average of 12 months The study endpoint is dose-limiting toxicity (DLT), which is defined as a treatment-related AE of Grade 3 or higher.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States