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

Malignant Central Nervous System Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04276194
• Other study ID #: IRB00113121
• Secondary ID: NCI-2019-05118P3
• Status: Completed
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: February 9, 2024

Study information

• Verified date: March 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 9, 2024
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• Malignant Central Nervous System Neoplasm
• Nervous System Neoplasms

Intervention

Procedure:
• Intensity-Modulated Proton Therapy
Undergo intensity modulated proton therapy
• Magnetic Resonance Imaging
Undergo MRI

Locations

Country	Name	City	State
United States	Emory Proton Therapy Center	Atlanta	Georgia
United States	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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