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

NCT04276194 | Completed DMC

• 4 other identifiers: IRB00113121NCI-2019-05118P30CA138292RAD4737-19
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Malignant Central Nervous System Neoplasm

Keywords

Craniospinal; Proton Therapy; Pediatric

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Treatment (intensity modulated proton therapy)

EXPERIMENTAL

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: Intensity-Modulated Proton Therapy; Procedure: Magnetic Resonance Imaging

Interventions

Intensity-Modulated Proton Therapy PROCEDURE

Undergo intensity modulated proton therapy

Also known as: IMPT

Treatment (intensity modulated proton therapy)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, nuclear magnetic resonance imaging

Treatment (intensity modulated proton therapy)

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Emory Proton Therapy Center

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Bree R Eaton

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 19, 2020
• Study Start: December 16, 2019
• Primary Completion: November 3, 2021
• Study Completion: February 9, 2024
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

US (2)