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

URL:

https://clinicaltrials.gov/show/NCT02245997

Trial Eligibility

Document

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

  • ORG STUDY ID: 14-186
  • NCT ID: NCT02245997

Conditions

  • Neuroblastoma

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
patients with high-risk neuroblastomaExperimentalPatients undergo external beam radiation therapy using IMRT or proton beam RT twice daily for 5-6 weekdays (10-12 treatments). Patients will be evaluated by physical exams, CT scan or MRI of the primary site, and MIBG at, 6, 12, 18 and 24 months (+/- 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 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.
    Maximum Eligible Age:18 Years
    Minimum Eligible Age:12 Months
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:assess local control rates treatment response
    Time Frame:3 yeas
    Safety Issue:
    Description: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 Outcome Measures

    Measure:event-free survival
    Time Frame:3 years
    Safety Issue:
    Description: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.
    Measure:Assessment of toxicity
    Time Frame:3 years
    Safety Issue:
    Description:will occur at the pre-specified follow-up time-points using the CTCAE version 4.0 grading system.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Memorial Sloan Kettering Cancer Center

    Trial Keywords

    • Reduced-dose Radiotherapy
    • 14-186

    Last Updated

    October 30, 2020