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 28, 2020
This research study is studying proton radiation as a possible treatment for brain tumor that requires radiation.
The radiation involved in this study is:
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor||Radiation: Proton Beam||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Craniospinal Irradiation Using Proton Beam Scanning With Selective Vertebral Body/Bone Sparing to Improve Marrow Reserve and Decrease Growth Decrement for Children|
|Actual Study Start Date :||January 4, 2018|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2025|
Experimental: Proton Radiotherapy
Radiation: Proton Beam
precision radiation that reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue
- 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.
- 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.
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
|Contact: Shannon MacDonald, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02214|
|Contact: Shannon MacDonald, MD 617-643-7250 email@example.com|
|Principal Investigator: Shannon MacDonald, MD|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Susan McGovern, MD firstname.lastname@example.org|
|Principal Investigator: Susan McGovern, MD|
|Principal Investigator:||Shannon MacDonald, MD||Massachusetts General Hospital|