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

Neuroblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02245997
• Other study ID #: 14-186
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2014
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Radiation:
• External beam radiotherapy

• proton beam RT

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Assessment of toxicity	will occur at the pre-specified follow-up time-points using the CTCAE version 4.0 grading system.	3 years

External Links

•   Memorial Sloan Kettering Cancer Center