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, 2022
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Condition or disease | Intervention/treatment | Phase |
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Neuroblastoma | Radiation: External beam radiotherapy Radiation: proton beam RT | Not Applicable |
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 2024 |
Estimated Study Completion Date : | September 2024 |

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).
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Radiation: External beam radiotherapy
Other Name: IMRT Radiation: proton beam RT |
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 12 Months to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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
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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
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Age > 18 months with unfavorable pathology, regardless of MYCN status
o Patients with INSS stage 2a or 2b are eligible with the following:
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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.

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
Contact: Suzanne Wolden, MD | 212-639-5148 | ||
Contact: Brian Kushner, MD | 212-639-6793 |
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 |
Principal Investigator: | Suzanne Wolden, MD | Memorial Sloan Kettering Cancer Center |
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, 2022 |
Last Verified: | October 2022 |
Reduced-dose Radiotherapy 14-186 |
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 |