Proton Craniospinal Irradiation With Bone Sparing to Decrease Growth Decrement From Radiation (NCT03281889) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Proton Craniospinal Irradiation With Bone Sparing to Decrease Growth Decrement From Radiation
United States20 participantsStarted 2018-01-04
Plain-language 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
Who can participate
Age range3 Years – 18 Years
SexALL
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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.
What they're measuring
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.