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Completed

NCT Number: NCT02245997

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

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

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Key information

Age range

12 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

External Beam Radiotherapy

Radiation

Other names: IMRT

proton beam RT

Radiation

Primary outcomes

  1. assess local control rates treatment response

    Time frame: 3 yeas

    will be assessed via imaging (CT+/- MRI and MIBG) and clinical evidence at the primary site post completion of treatment. The baseline scan will be the pre-irradiation CT scan. Local failure is defined as a relapse in the primary tumor bed or adjacent lymph nodes.

Secondary outcomes

  1. event-free survival

    Time frame: 3 years

    will be performed for each patient using clinical data and imaging. Events are defined as failure (loco-regional and/or distant), treatment-related malignancy, or death.

  2. Assessment of toxicity

    Time frame: 3 years

    will occur at the pre-specified follow-up time-points using the CTCAE version 4.0 grading system.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2014
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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