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Response- and Biology-Based Therapy for Intermediate-Risk Neuroblastoma

Unique Dataset IDNCT00499616
SponsorChildren's Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients464RandomizationNoPubMed (PMID)31386611.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeN/ADataset TypeOther

Clinical Trial Title

Response- and Biology-Based Therapy for Intermediate-Risk Neuroblastoma

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Isotretinoin may help neuroblastoma cells become more like normal cells, and grow and spread more slowly. Giving combination chemotherapy before surgery may make the tumor smaller and make it more likely that the tumor can be surgically removed. It is not yet known what is the minimal amount of chemotherapy needed to achieve sufficient tumor shrinkage to control intermediate risk neuroblastoma and prevent tumor recurrence or metastases. PURPOSE: This phase III trial is designed to reduce therapy for patients with favorable biology intermediate risk neuroblastoma by decreasing the number of chemotherapy cycles administered and by allowing for up to 50% residual tumor volume for patients with localized disease.

Data Summary

See Data Dictionary.

Study Objectives


Outcome Measures

Primary: Overall Survival (OS) Rates [ Time Frame: 3 years ]; Definitive Determination of the Prognostic Ability of 1p and 11q [ Time Frame: At baseline ]; Comparison Between Reduce Intensity of Therapy for Patients With Stage 4 Neuroblastoma and Favorable Biological Features and Patients < 1 Year of Age With Stage 4 Neuroblastoma Treated on COG-A3961 [ Time Frame: Up to 3 years ]; Comparison Between Reduce Intensity of Therapy for Patients With Unfavorable Histology Neuroblastoma and Patients Unfavorable Histology Neuroblastoma Treated on COG-A3961 [ Time Frame: Up to 3 years ]; Reduced Surgical Morbidity for Patients With Stage 4S Neuroblastoma [ Time Frame: Up to 3 years ]; Outcome of Patients With Stage 4S Neuroblastoma Who Are Unable to Undergo Biopsy for Biology-based Risk Assignment [ Time Frame: From baseline to up to 10 years ]; Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Event Free Survival (EFS) [ Time Frame: Up to 10 years ].

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

There are two datasets associated with the publication: NCT00499616?D6 and NCT00499616?D7. USI is the patient identifier in all datasets. Blanks represent missing data or not applicable for analyses. Data can be used to approximate published study findings, but exact reproduction of previous manuscripts may not be possible in some cases (e.g., when data must be modified for de-identification purposes or have undergone further data cleaning). NCT00499616?D6: There is one row for each patient enrolled on ANBL0531. The dataset provided provides the information necessary to reproduce the manuscript, except for the toxicities.

Available Downloads: NCT00499616-D6

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00499616-D6-Data-Dictionary_3.pdf

DATA: NCT00499616-D6-Dataset_3.csv


Available Downloads: NCT00499616-D7

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00499616-D7-Data-Dictionary_2.pdf

DATA: NCT00499616-D7-Dataset_2.csv