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

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ClinicalTrials.gov Identifier: NCT02245997
Recruitment Status : Recruiting
First Posted : September 22, 2014
Last Update Posted : November 1, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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

Condition or disease Intervention/treatment Phase
Neuroblastoma Radiation: External beam radiotherapy Radiation: proton beam RT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma
Study Start Date : September 2014
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma

Arm Intervention/treatment
Experimental: patients with high-risk neuroblastoma
Patients 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).
Radiation: External beam radiotherapy
Other Name: IMRT

Radiation: proton beam RT



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245997


Contacts
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Contact: Suzanne Wolden, MD 212-639-5148
Contact: Brian Kushner, MD 212-639-6793

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Suzanne Wolden, MD    212-639-5148      
Contact: Leonard Wexler, MD    212-639-7990      
Principal Investigator: Suzanne Wolden, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Suzanne Wolden, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02245997    
Other Study ID Numbers: 14-186
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021
Keywords provided by Memorial Sloan Kettering Cancer Center:
Reduced-dose Radiotherapy
14-186
Additional relevant MeSH terms:
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Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue