ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Craniospinal Irradiation Using Proton Beam Scanning With Selective Vertebral Body/Bone Sparing to Improve Marrow Reserve and Decrease Growth Decrement for Children

Quick Facts

Study Start:2018-01-04

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03281889

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Principal Investigator

Shannon MacDonald, MD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02214

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Shannon MacDonald, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-01-04

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2018-01-04

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

Brain Tumor

Additional Relevant MeSH Terms

Brain Tumor