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

NCT ID: NCT03281889

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-04
• Study Completion Date: 2027-12-31

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

Conditions

Brain Tumor

Keywords

Brain Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Proton Beam

Intervention Type: RADIATION

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

Interventions

Proton Beam

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

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kevin X. Liu, MD, DPHIL

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shannon MacDonald, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

U19CA021239-37

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-283

Identifier Type: -

Identifier Source: org_study_id