Back to resultsProton Craniospinal Irradiation With Bone Sparing to Decrease Growth Decrement From Radiation
Primary Purpose
Brain Tumor
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton Beam
Sponsored by
About this trial
This is an interventional treatment trial for Brain Tumor focused on measuring Brain Tumor
Eligibility 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.
Sites / Locations
- Massachusetts General HospitalRecruiting
- MD Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Proton Radiotherapy
Arm Description
Patients will be treated with Proton Beam once daily 5 days per week. Doses will be prescribed such that maximum possible coverage is achieved
Outcomes
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.
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
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
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
Summary of the changes in the participants sitting and standing heights.
Time to abnormality in spinal curvature
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
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
Summary of the sites where the cancer relapses. Relapse is the regrowth of cancer cells.
Complete blood counts (CBC) over time
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
Summary of the changes in blood levels of vitamin D, calcium, and growth hormones.
Weight
Summary of the changes in weight of the participants as assessed by yearly evaluations.
BMI
Summary of the body mass index (BMI) of the participants as assessed by yearly physical evaluations.
Full Information
NCT ID
NCT03281889
First Posted
September 8, 2017
Last Updated
January 3, 2021
Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03281889
Brief Title
Proton Craniospinal Irradiation With Bone Sparing to Decrease Growth Decrement From Radiation
Official Title
Craniospinal Irradiation Using Proton Beam Scanning With Selective Vertebral Body/Bone Sparing to Improve Marrow Reserve and Decrease Growth Decrement for Children
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor
Keywords
Brain Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Proton Radiotherapy
Arm Type
Experimental
Arm Description
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 Type
Radiation
Intervention Name(s)
Proton Beam
Intervention Description
precision radiation that reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Early marrow changes in the vertebral bodies
Description
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.
Time Frame
2 years
Title
Vertebral column growth (measured by MRI) over 5 years
Description
Summary of vertebral column growth (measured by MRI) over 5 years following vertebral body sparing cranio-spinal irradiation in pediatric patients.
Time Frame
Annually for 5 years
Title
Change in sitting height and standing height
Description
Summary of the changes in the participants sitting and standing heights.
Time Frame
Annually for 5 years
Title
Time to abnormality in spinal curvature
Description
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.
Time Frame
5 years
Title
Disease Free Survival
Description
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.
Time Frame
5 years
Title
Pattern of Disease Relapse
Description
Summary of the sites where the cancer relapses. Relapse is the regrowth of cancer cells.
Time Frame
2 years
Title
Complete blood counts (CBC) over time
Description
Summary of the change in complete blood counts (CBC) over time as determined by yearly blood samples.
Time Frame
Annually for 5 years
Title
Change in levels of vitamin D, calcium, and growth hormones over time
Description
Summary of the changes in blood levels of vitamin D, calcium, and growth hormones.
Time Frame
Annually for 5 years
Title
Weight
Description
Summary of the changes in weight of the participants as assessed by yearly evaluations.
Time Frame
Annually for 5 years
Title
BMI
Description
Summary of the body mass index (BMI) of the participants as assessed by yearly physical evaluations.
Time Frame
Annually for 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon MacDonald, MD
Phone
617-643-7250
Email
smacdonald@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon MacDonald, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon MacDonald, MD
Phone
617-643-7250
Email
smacdonald@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Shannon MacDonald, MD
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan McGovern, MD
Email
slmcgove@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Susan McGovern, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Proton Craniospinal Irradiation With Bone Sparing to Decrease Growth Decrement From Radiation
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