Clinical Trials Logo

Clinical Trial Summary

This trial studies the feasibility of using intensity modulated proton therapy to deliver craniospinal irradiation while avoiding the bones of the vertebral column. Intensity modulated proton therapy is an advanced radiation therapy modality that uses high energy protons to kill cancer cells and shrink tumors, and may reduce the side effects of treatment by reducing radiation exposure to the spinal column.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To demonstrate the feasibility and safety of using intensity modulated proton therapy to deliver vertebral body sparing craniospinal irradiation in growing children. Ia. To report the dose received to the vertebral bodies and the dose gradient/heterogeneity within the vertebral body. Ib. To document, using weekly cone beam computed tomography (CT) of the cervical and lumbar spine, delivered dose in comparison with planned dose after accounting for any errors in patient positioning. II. To evaluate acute toxicity of vertebral body sparing (VBS) craniospinal irradiation (CSI). IIa. To report absolute lymphocyte counts over time and occurrence of grade 3-4 hematological toxicity. IIb. To report the incidence and severity of any grade esophagitis during or within 4 weeks of radiation therapy. III. To evaluate the feasibility of magnetic resonance imaging (MRI) imaging during CSI therapy as in vivo proton range verification. IIIa. To demonstrate the feasibility of completing interim non-contrast MRIs of the spine during treatment. IIIb. To characterize the earliest time point at which radiation induced bone marrow changes can be detected in children receiving proton CSI. OUTLINE: Patients undergo intensity modulated proton therapy once daily over 30 fractions and also undergo MRI over 20 minutes during fractions 7, 13, 20, and 30 of radiation in the absence of disease progression or unacceptable toxicity. After the completion of study treatment, patients are followed up at 4 weeks and then every 3-12 months thereafter. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04276194
Study type Interventional
Source Emory University
Contact
Status Completed
Phase N/A
Start date December 16, 2019
Completion date February 9, 2024

See also
  Status Clinical Trial Phase
Completed NCT03565367 - Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Detecting Lactate and Bicarbonate in Participants With Central Nervous System Tumors Phase 1
Recruiting NCT00991094 - Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy
Completed NCT04456140 - Pro-Active Genetic Testing in Patients With Solid Tumors, Inherit Study Phase 1
Not yet recruiting NCT05720624 - Pharmacodynamic Analyses of Metabolic Agents Following Brain Radiation Phase 1
Completed NCT04296617 - Brain Imaging Changes Following Proton Therapy for Pediatric Primary Central Nervous System and Base of Skull Tumors
Recruiting NCT06117930 - Study of Human Brain-Gut Axis and Gut Microbiome in Patients With Brain Lesions - Repository for Neuroscience Research
Active, not recruiting NCT04217694 - Memantine for the Reduction of Cognitive Impairment After Radiation Therapy in Pediatric Patients With Central Nervous System Tumors Early Phase 1