Local Control With Reduced-dose Radiotherapy for High-Ris... | NCT02245997

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

NCT02245997

Sponsor

Memorial Sloan Kettering Cancer Center

Status

Completed

Last Update Posted

Sep 29, 2025Actual

Enrollment

78Actual

Phase

Early Phase 1

Conditions

Neuroblastoma

Interventions

External beam radiotherapy
proton beam RT

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

May 1, 2025Actual

Completion Date

May 1, 2025Actual

First Submitted Date

Sep 17, 2014

First Submission Date that Met QC Criteria

Sep 18, 2014

First Posted Date

Sep 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2025

Last Update Posted Date

Sep 29, 2025Actual

Label	Type	Description	Intervention Names
patients with high-risk neuroblastoma	Experimental	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 Radiation: proton beam RT

Name	Type	Description	Arm Group Labels	Other Names
External beam radiotherapy	Radiation		patients with high-risk neuroblastoma	IMRT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
assess local control rates treatment response	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.	3 yeas

Secondary Outcomes

Measure	Description	Time Frame
event-free survival	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.	3 years
Assessment of toxicity

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D018241	Neuroectodermal Tumors, Primitive, Peripheral
D018242	Neuroectodermal Tumors, Primitive
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors