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

University of Arkansas

Status: Terminated

Conditions: Radiation Toxicity; Osteosarcoma in Children

Treatments: Radiation: GRID radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03139318

205993

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 5 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

1 participants in 1 patient group

GRID Radiotherapy

Experimental group

Description:

Patients will be treated with GRID Radiotherapy

Treatment:

Radiation: GRID radiotherapy