Description:
The purpose of this study is to give 12T a smaller dose of radiation in order to decrease these late side effects.
The purpose of this study is to give 12T a smaller dose of radiation in order to decrease these late side effects.
Recruiting
N/A
Name | Type | Description | Interventions |
---|---|---|---|
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). |
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.
Maximum Eligible Age: | 18 Years |
Minimum Eligible Age: | 12 Months |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | assess local control rates treatment response |
Time Frame: | 3 yeas |
Safety Issue: | |
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. |
Measure: | event-free survival |
Time Frame: | 3 years |
Safety Issue: | |
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. |
Measure: | Assessment of toxicity |
Time Frame: | 3 years |
Safety Issue: | |
Description: | will occur at the pre-specified follow-up time-points using the CTCAE version 4.0 grading system. |
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
October 30, 2020