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

This study is not yet open for participant recruitment.
Verified September 2017 by Shannon MacDonald, MD, Massachusetts General Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03281889
First Posted: September 13, 2017
Last Update Posted: September 13, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Shannon MacDonald, MD, Massachusetts General Hospital
  Purpose

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


Condition Intervention
Brain Tumor Radiation: Proton Beam

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Craniospinal Irradiation Using Proton Beam Scanning With Selective Vertebral Body/Bone Sparing to Improve Marrow Reserve and Decrease Growth Decrement for Children

Resource links provided by NLM:


Further study details as provided by Shannon MacDonald, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Anticipated Study Start Date: September 30, 2017
Estimated Study Completion Date: March 31, 2025
Estimated Primary Completion Date: March 31, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Radiation: Proton Beam
precision radiation that reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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): NCT03281889


Contacts
Contact: Jill McElroy 617-724-3744 jsmcelroy@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02214
Contact: Jill McElroy    617-724-3744    jsmcelroy@mgh.harvard.edu   
Principal Investigator: Shannon MacDonald, MD         
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Investigators
Principal Investigator: Shannon MacDonald, MD Massachusetts General Hospital
  More Information

Responsible Party: Shannon MacDonald, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03281889     History of Changes
Other Study ID Numbers: 17-283
U19CA021239-37 ( U.S. NIH Grant/Contract )
First Submitted: September 8, 2017
First Posted: September 13, 2017
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Shannon MacDonald, MD, Massachusetts General Hospital:
Brain Tumor

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases