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