Clinical trial NCT02245997: Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma
Official title: Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuroblastoma
Keywords: Reduced-dose Radiotherapy
14-186
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 78
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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 1-18 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 month 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.

Primary outcomes:
measure: assess local control rates treatment response
timeFrame: 3 yeas
Secondary outcomes:
measure: event-free survival
timeFrame: 3 years
measure: Assessment of toxicity
timeFrame: 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Suzanne Wolden, MD
role: PRINCIPAL_INVESTIGATOR
References: