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
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Radiation: External beam radiotherapy Radiation: proton beam RT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
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|