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

Brain Tumor Clinical Trial

Official title:

Craniospinal Irradiation Using Proton Beam Scanning With Selective Vertebral Body/Bone Sparing to Improve Marrow Reserve and Decrease Growth Decrement for Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03281889
• Other study ID #: 17-283
• Secondary ID: U19CA021239-37
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2018
• Est. completion date: March 31, 2025

Study information

• Verified date: January 2021
• Source: Massachusetts General Hospital
• Contact: Shannon MacDonald, MD
• Phone: 617-643-7250
• Email: smacdonald[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

Radiation:
• Proton Beam
precision radiation that reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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.	2 years
Secondary	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.	Annually for 5 years
Secondary	Change in sitting height and standing height	Summary of the changes in the participants sitting and standing heights.	Annually for 5 years
Secondary	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.	5 years
Secondary	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.	5 years
Secondary	Pattern of Disease Relapse	Summary of the sites where the cancer relapses. Relapse is the regrowth of cancer cells.	2 years
Secondary	Complete blood counts (CBC) over time	Summary of the change in complete blood counts (CBC) over time as determined by yearly blood samples.	Annually for 5 years
Secondary	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.	Annually for 5 years
Secondary	Weight	Summary of the changes in weight of the participants as assessed by yearly evaluations.	Annually for 5 years
Secondary	BMI	Summary of the body mass index (BMI) of the participants as assessed by yearly physical evaluations.	Annually for 5 years