Observational Trial of the Impact of Radiation Dose in Children With Brain and Skull Base Tumors.

Baptist Health South Florida

Status: Active, not recruiting

Conditions: Brain Tumor; Skull Base Tumor; Brain Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03972514

2018-LLB-HALL-001

Details and patient eligibility

About

This is a prospective, observational clinical trial investigating the morphological and volumetric changes in the brain following cranial Radiation Therapy in pediatric patients with brain or skull base tumors.

Full description

Brain injury is a known complication of cranial RT, but little is known about the factors that predispose patients to such injury. The brain is a highly interconnected organ linked through neuronal connections, cellular migration, and vascular supply and is endowed with exquisitely radiosensitive stem cell niches responsible for neuro-regeneration. To date, the effects of brain radiation have been quantified in few brain substructures. The majority of publications on this topic have focused on regions receiving higher doses. Even low dose radiation exposure, however has global implications on brain development and function, and its effects are less well studied. It is increasingly recognized that radiation damage to one brain region can potentially affect brain development more broadly. This has important implications on RT planning and the potential for understanding its long-term effects.

In this protocol, the investigators aim to measure serum inflammatory cytokine levels and other molecular biomarkers at baseline and post-exposure in an exploratory manner to investigate potential associations with the risk of developing volumetric changes in the brain and radiation-induced toxicities.

This study will observe sixty (60) patients under the age of 21 with brain or base of skull tumor. The study team will observe the effect of radiation therapy per the study protocol versus standard of care.

Enrollment: 60 patients

Sex: All

Ages: 1 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient (parent) must give study-specific informed consent on an IRB-approved consent prior to any research related procedures or study treatment. Written assent will be obtained as per Institutional guidelines.
• Patients (Age equal to or less than 35 years old) that are planned to receive photon or proton RT to the brain according to standard of care are eligible to participate.
• Patients that are planned to receive fractionated RT at 1.2-2.0 Gy RBE dose per fraction per standard of care are eligible to participate. If patients are planned to receive an alternative dose/fractionation regimen, then they should be treated according to standard of care and should not be enrolled.
• Zubrod/Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1

Exclusion criteria

• Patient cannot undergo MRI without contrast as per standard of care
• Patient and family do not speak English or Spanish
• Patient receiving treatment with non-curative intent
• Patients with an expected 3-year overall survival less than 50%