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

Primary Purpose

Neuroblastoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
External beam radiotherapy
proton beam RT
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring Reduced-dose Radiotherapy, 14-186

Eligibility Criteria

12 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with high-risk neuroblastoma

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Assessment of toxicity
will occur at the pre-specified follow-up time-points using the CTCAE version 4.0 grading system.

Full Information

First Posted
September 17, 2014
Last Updated
October 31, 2022
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02245997
Brief Title
Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma
Official Title
Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma
Keywords
Reduced-dose Radiotherapy, 14-186

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with high-risk neuroblastoma
Arm Type
Experimental
Arm Description
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).
Intervention Type
Radiation
Intervention Name(s)
External beam radiotherapy
Other Intervention Name(s)
IMRT
Intervention Type
Radiation
Intervention Name(s)
proton beam RT
Primary Outcome Measure Information:
Title
assess local control rates treatment response
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.
Time Frame
3 yeas
Secondary Outcome Measure Information:
Title
event-free survival
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.
Time Frame
3 years
Title
Assessment of toxicity
Description
will occur at the pre-specified follow-up time-points using the CTCAE version 4.0 grading system.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzanne Wolden, MD
Phone
212-639-5148
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Kushner, MD
Phone
212-639-6793
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Wolden, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Wolden, MD
Phone
212-639-5148
First Name & Middle Initial & Last Name & Degree
Leonard Wexler, MD
Phone
212-639-7990
First Name & Middle Initial & Last Name & Degree
Suzanne Wolden, MD

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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