Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 18
Updated:2/3/2019
Start Date:September 2014
End Date:September 2020
Contact:Suzanne Wolden, MD
Phone:212-639-5148

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The purpose of this study is to give 12T a smaller dose of radiation in order to decrease
these late side effects.


Inclusion Criteria:

- Patients must have a diagnosis of neuroblastoma (International Classification of
Disease for Oncology [ICD-O] morphology 9500/3) confirmed by MSKCC pathologic review

- Patients must have high-risk neuroblastoma as defined by the COG Risk Stratification
Schema

o Patients with International agreement on staging (INSS) stage 4 are eligible with
the following:

- MYCN amplification, regardless of age or additional biologic features

- Age >18 months, regardless of biologic features OR

- Age 12-18 months, with any of the 3 following unfavorable biologic OR features: MYCN
amplification, unfavorable pathology, and/or DNA index = 1

o Patients with INSS stage 3 are eligible with the following:

- MYCN amplification, regardless of age or additional biologic features OR

- Age > 18 months with unfavorable pathology, regardless of MYCN status

o Patients with INSS stage 2a or 2b are eligible with the following:

- MYCN amplification, regardless of age or additional biologic features

o Patients with INSS stage 4s are eligible with the following:

- MYCN amplification, regardless of additional biologic features Patients must have
undergone chemotherapy and surgery for high-risk neuroblastoma prior to enrollment on
trial.

- Age at time of enrollment of ≥1 year and ≤18 years

- Female patients of childbearing potential must have a negative pregnancy test within
14 days of radiation start.

- Female patients who are lactating must agree to stop breast-feeding.

- Sexually active patients of childbearing potential must agree to use effective
contraception.

Exclusion Criteria:

- Patients with gross residual tumor after surgical resection

- Patients who have received prior radiotherapy at or adjacent to the primary tumor bed

- Patients with any concurrent medical or psychiatric condition or disease which, in the
investigator's judgment, would make them inappropriate candidates for entry into this
study.
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Suzanne Wolden, MD
Phone: 212-639-5148
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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