Clinical trial NCT03281889: Proton Craniospinal Irradiation With Bone Sparing to Decrease Growth Decrement From Radiation
Official title: Craniospinal Irradiation Using Proton Beam Scanning With Selective Vertebral Body/Bone Sparing to Improve Marrow Reserve and Decrease Growth Decrement for Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Tumor
Keywords: Brain Tumor
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-09-13
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: 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.
timeFrame: 3 months
Secondary outcomes:
measure: Early marrow changes in the vertebral bodies
timeFrame: 2 years
measure: Vertebral column growth (measured by MRI) over 5 years
timeFrame: Annually for 5 years
measure: Change in sitting height and standing height
timeFrame: Annually for 5 years
measure: Time to abnormality in spinal curvature
timeFrame: 5 years
measure: Disease Free Survival
timeFrame: 5 years
measure: Pattern of Disease Relapse
timeFrame: 2 years
measure: Complete blood counts (CBC) over time
timeFrame: Annually for 5 years
measure: Change in levels of vitamin D, calcium, and growth hormones over time
timeFrame: Annually for 5 years
measure: Weight
timeFrame: Annually for 5 years
measure: BMI
timeFrame: Annually for 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Massachusetts General Hospital
name: Shannon MacDonald, MD
role: PRINCIPAL_INVESTIGATOR
References: