Vertebral Body Sparing Craniospinal Irradiation for Pediatric Patients With Cancer of the Central Nervous System

Feasibility of Vertebral Body Sparing Intensity Modulated Proton Therapy Craniospinal Irradiation With in Vivo Range Verification in Growing Children

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.

Study Overview

• Status: Completed
• Conditions: Malignant Central Nervous System Neoplasm
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging; Procedure: Intensity-Modulated Proton Therapy

Detailed 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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital/Winship Cancer Institute
    • Atlanta, Georgia, United States, 30308
      • Emory Proton Therapy Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pathologic diagnosis of central nervous system malignancy requiring craniospinal irradiation.
• Signed informed consent and assent when indicated.

Exclusion Criteria:

• Any contraindication to undergoing MRI (ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial cardiac valves or devices, electrical implants such as cardiac pacemakers or perfusion pumps). Metal fragments, shrapnel, or tattoos near the eye.
• Any major uncontrolled or poorly controlled current illness that would limit compliance with study requirements.
• Pregnant females are excluded. Females of childbearing age/menstruating must confirm that either they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (intensity modulated proton therapy); 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.	Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR Imaging; MRI Scan; NMR Imaging; NMRI; nuclear magnetic resonance imaging; Procedure: Intensity-Modulated Proton Therapy; Undergo intensity modulated proton therapy; Other Names: IMPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of acute hematologic toxicity	Will be graded according to Common Terminology Criteria for Adverse Events version 5.0.	Up to 2 years
Dose delivered to vertebral bodies and quality assurance of treatment plans	Multiple measurements will be aggregated to arrive at one reported value when toxicities are graded (1-5). Dose statistics are in units of Gy or may be %	Up to 2 years
Bone marrow changes on MRI	Will be quantitatively and qualitatively analyzed in relationship to the proton dose distribution	At baseline, and fractions 7, 13, 20, and 30 of radiation therapy

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Bree R Eaton, Emory University Hospital/Winship Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Actual): November 3, 2021
• Study Completion (Actual): February 9, 2024

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric; Proton Therapy; Craniospinal
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Neoplasms by Site; Nervous System Neoplasms; Central Nervous System Neoplasms
• Other Study ID Numbers: IRB00113121; P30CA138292 (U.S. NIH Grant/Contract); NCI-2019-05118 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); RAD4737-19 (Other Identifier: Emory University Hospital/Winship Cancer Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No