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

NCT03281889 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: 17-283U19CA021239-37
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Conditions

Brain Tumor

Keywords

Brain Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Early marrow changes in the vertebral bodies

  2 years

• Vertebral column growth (measured by MRI) over 1 year

  Last day of treatment to 1 year later

• Change in sitting height and standing height

  Annually for 5 years

• Time to abnormality in spinal curvature

  5 years

• Disease Free Survival

  5 years

Study Arms (1)

Proton Radiotherapy

EXPERIMENTAL

* 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

Interventions

Proton Beam RADIATION

precision radiation that reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue

Proton Radiotherapy

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Shannon MacDonald, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 13, 2017
• Study Start: January 4, 2018
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)