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Trial record 2 of 23 for:    Recruiting, Enrolling by invitation Studies | Interventional Studies | CNS Cancer | United States | First posted from 01/01/2020 to 06/24/2020

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04276194
Recruitment Status : Recruiting
First Posted : February 19, 2020
Last Update Posted : February 19, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bree Eaton, Emory University

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.

Condition or disease Intervention/treatment Phase
Malignant Central Nervous System Neoplasm Procedure: Intensity-Modulated Proton Therapy Procedure: Magnetic Resonance Imaging Not Applicable

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.

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Study Type : Interventional
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Vertebral Body Sparing Intensity Modulated Proton Therapy Craniospinal Irradiation With in Vivo Range Verification in Growing Children
Actual Study Start Date : December 16, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

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: Intensity-Modulated Proton Therapy
Undergo intensity modulated proton therapy
Other Name: IMPT

Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR Imaging
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • nuclear magnetic resonance imaging




Primary Outcome Measures :
  1. Incidence and severity of acute hematologic toxicity [ Time Frame: Up to 2 years ]
    Will be graded according to Common Terminology Criteria for Adverse Events version 5.0.

  2. Dose delivered to vertebral bodies and quality assurance of treatment plans [ Time Frame: Up to 2 years ]
    Dose statistics from proton therapy planning and weekly quality assurance cone beam CT

  3. Bone marrow changes on MRI [ Time Frame: At baseline, and fractions 7, 13, 20, and 30 of radiation therapy ]
    Will be quantitatively and qualitatively analyzed in relationship to the proton dose distribution



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276194


Locations
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United States, Georgia
Emory Proton Therapy Center Recruiting
Atlanta, Georgia, United States, 30308
Contact: Bree R Eaton, MD    404-251-1245    brupper@emory.edu   
Contact: Allyson Anderson    404-251-2845    allyson.anderson@emory.edu   
Emory University Hospital/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Bree R. Eaton, MD    404-778-3473    brupper@emory.edu   
Principal Investigator: Bree R. Eaton         
Sponsors and Collaborators
Emory University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Bree R Eaton Emory University Hospital/Winship Cancer Institute
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Responsible Party: Bree Eaton, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT04276194    
Other Study ID Numbers: IRB00113121
NCI-2019-05118 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA138292 ( U.S. NIH Grant/Contract )
First Posted: February 19, 2020    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bree Eaton, Emory University:
Craniospinal
Proton Therapy
Pediatric
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases