Clinical Trials /

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

NCT02245997

Description:

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

Related Conditions:
  • Neuroblastoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Local Control With Reduced-dose <span class="go-doc-concept go-doc-intervention">Radiotherapy</span> for High-Risk <span class="go-doc-concept go-doc-disease">Neuroblastoma</span>

Title

  • Brief Title: Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma
  • Official Title: Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma
  • Clinical Trial IDs

    NCT ID: NCT02245997

    ORG ID: 14-186

    Trial Conditions

    Neuroblastoma

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

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

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    patients with high-risk neuroblastoma Experimental External beam radiotherapy to the post-induction, pre-surgical primary tumor bed with 15-18 Gy radiotherapy on protocol. Assessment of local control every 3 months for 2 years (all visits +/- 6 weeks).

    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 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.

    Minimum Eligible Age: 12 Months

    Maximum Eligible Age: 18 Years

    Eligible Gender: Both

    Primary Outcome Measures

    assess local control rates

    Secondary Outcome Measures

    event-free survival

    Assessment of toxicity

    Trial Keywords

    Reduced-dose Radiotherapy

    14-186