Status:
ACTIVE_NOT_RECRUITING
Proton Craniospinal Irradiation With Bone Sparing to Decrease Growth Decrement From Radiation
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain Tumor
Eligibility:
All Genders
3-18 years
Phase:
NA
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03281889
Start Date
January 4 2018
End Date
December 31 2027
Last Update
November 7 2025
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030