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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2025
  • participants needed
    20
  • sponsor
    Massachusetts General Hospital
Updated on 27 January 2021
cancer
ependymoma
low grade glioma
medulloblastoma
germ cell tumor

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

Details
Condition Malignant neoplasm of brain, Brain Cancer, Brain Tumor, Brain Tumor (Pediatric), Brain Tumor (Pediatric), Brain Cancer, Brain Tumor, brain tumors
Treatment Proton beam
Clinical Study IdentifierNCT03281889
SponsorMassachusetts General Hospital
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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