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Proton Craniospinal Irradiation With Bone Sparing to Decrease Growth Decrement From Radiation

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: NCT03281889
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : January 5, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Shannon MacDonald, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE September 8, 2017
First Posted Date  ICMJE September 13, 2017
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE January 4, 2018
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
Feasibility of cranio-spinal irradiation (CSI) utilizing intensity-modulated proton therapy (IMPT) with pencil beam scanning (PBS) for vertebral body sparing (VBS) in pediatric patients. [ Time Frame: 3 months ]
IMPT using PBS delivery will be considered to be feasible as a VBS technique for CSI in pediatric patients if the rate of grade 3/4 hematologic toxicity were no more than 5% within 3 months after the completion of radiation treatment, within the range associated with conventional techniques of CSI. Toxicity will be assess using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
  • Early marrow changes in the vertebral bodies [ Time Frame: 2 years ]
    Summary of early marrow changes in the vertebral bodies by Magnetic resonance imaging (MRI) of the spine during radiation therapy (RT) by comparing one study MRI to the baseline pre-RT MRI.
  • Vertebral column growth (measured by MRI) over 5 years [ Time Frame: Annually for 5 years ]
    Summary of vertebral column growth (measured by MRI) over 5 years following vertebral body sparing cranio-spinal irradiation in pediatric patients.
  • Change in sitting height and standing height [ Time Frame: Annually for 5 years ]
    Summary of the changes in the participants sitting and standing heights.
  • Time to abnormality in spinal curvature [ Time Frame: 5 years ]
    Participants are monitored both clinically and by MRI for any abnormality in spinal curvature. The time to abnormality in spine curvature will be measured from the start of radiation to the date of documented abnormality or censored at the date of last follow-up for patients still alive with normal spine.
  • Disease Free Survival [ Time Frame: 5 years ]
    Disease-free survival is measured from the start of radiation to the date of progressive disease based on imaging studies obtained as standard care or to the date of death due to any cause, whichever is earlier. Disease-free survival will be estimated using the Kaplan-Meier method. Patients without progressive disease and still alive will be censored at their date of last contact.
  • Pattern of Disease Relapse [ Time Frame: 2 years ]
    Summary of the sites where the cancer relapses. Relapse is the regrowth of cancer cells.
  • Complete blood counts (CBC) over time [ Time Frame: Annually for 5 years ]
    Summary of the change in complete blood counts (CBC) over time as determined by yearly blood samples.
  • Change in levels of vitamin D, calcium, and growth hormones over time [ Time Frame: Annually for 5 years ]
    Summary of the changes in blood levels of vitamin D, calcium, and growth hormones.
  • Weight [ Time Frame: Annually for 5 years ]
    Summary of the changes in weight of the participants as assessed by yearly evaluations.
  • BMI [ Time Frame: Annually for 5 years ]
    Summary of the body mass index (BMI) of the participants as assessed by yearly physical evaluations.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Proton Craniospinal Irradiation With Bone Sparing to Decrease Growth Decrement From Radiation
Official Title  ICMJE Craniospinal Irradiation Using Proton Beam Scanning With Selective Vertebral Body/Bone Sparing to Improve Marrow Reserve and Decrease Growth Decrement for Children
Brief Summary

This research study is studying proton radiation as a possible treatment for brain tumor that requires radiation.

The radiation involved in this study is:

-Proton Radiation

Detailed Description

This research study is a Pilot Study to determine whether using proton therapy in participants that require craniospinal radiation (whole brain and spinal cord radiation therapy) with sparing of the bony spine will work. This is the first time investigators are examining bone sparing proton therapy in pediatric craniospinal radiation.

The FDA (the U.S. Food and Drug Administration) has not approved proton radiation for this specific disease but it has been approved for other uses.

In this research study, the investigators are studying proton radiation in participants that require craniospinal radiation. The standard of care for this procedure is photon radiation, which is very similar to proton radiation. The investigators believe that the precision of proton radiation may help to reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain Tumor
Intervention  ICMJE Radiation: Proton Beam
precision radiation that reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue
Study Arms  ICMJE Experimental: Proton Radiotherapy
  • Patients will be treated with Proton Beam once daily 5 days per week.
  • Doses will be prescribed such that maximum possible coverage is achieved
Intervention: Radiation: Proton Beam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 11, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2025
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 3 years and ≤ 18 years at the time of registration
  • Histologically proven malignancy necessitating cranio-spinal irradiation. This will include patients with a diagnosis of medulloblastoma, Supratentorial primitive neuroectodermal tumor (SPNET), germ cell tumor (GCT), disseminated ependymoma, embryonal tumor with abundant neuropil and true rosettes (ETANTR), Atypical Teratoid/Rhabdoid Tumor (ATRT), and disseminated low-grade glioma (LGG).
  • Life expectancy ≥ 12 months.
  • Signed informed consent document and assent when appropriate.
  • HGB of > 10 g/L and PLT count > 80 K/uL

Exclusion Criteria:

  • Any prior therapeutic radiation therapy > 500 cGy has been delivered.
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances: if they have been disease-free for at least 5 years and are deemed by the investigator to be a low-risk for recurrence of that malignancy; or, have had only cervical cancer in situ, or basal cell or squamous cell carcinoma of the skin.
  • Any major uncontrolled or poorly controlled intercurrent 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.
  • Patients that receive concurrent chemotherapy with the exception of concurrent Vincristine.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shannon MacDonald, MD 617-643-7250 smacdonald@mgh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03281889
Other Study ID Numbers  ICMJE 17-283
U19CA021239-37 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shannon MacDonald, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Shannon MacDonald, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP