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Type(s) of Cancer
Neuroblastoma
Study Phase
Phase 3
Study Completion Date
2014-06-30
NCT00499616Uploaded 09-15-2020
Access via NCI by Request
PDS UID: nci-data-425
Response- and Biology-Based Therapy for Intermediate-Risk Neuroblastoma
Provider Information
Provider Data DescriptionThere 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.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: 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.
ConditionsNeuroblastoma
Intervention TypeDrug: carboplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: topotecan hydrochloride
Drug: Isotretinoin
Procedure: Surgery
Drug: Filgrastim
Drug(s)Drug: carboplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: topotecan hydrochloride
Drug: Filgrastim
Drug: Isotretinoin
Total Enrolled464
RandomizationNon Randomized
Blinding MethodNone
Arms InterventionGroup 2 (chemotherapy, surgery) - Experimental
Group 3 (chemotherapy, surgery) - Experimental
Group 4 (chemotherapy, surgery, antineoplastic therapy) - Experimental
Non-intermediate risk enrolled on intermediate risk trial - Experimental
Secondary IDCOG-ANBL0531
PubMed (PMID)31386611
30444686
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Netherlands
New Zealand
Puerto Rico
Age Range12 Years and younger (CHILD)
Files: NCT00499616-D6
Data DictionaryNCT00499616-D6-Data-Dictionary_3.pdf
DATANCT00499616-D6-Dataset_3.csv
OTHERREADME.pdf
Files: NCT00499616-D7
Data DictionaryNCT00499616-D7-Data-Dictionary_2.pdf
DATANCT00499616-D7-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00499616-D1
Data DictionaryNCT00499616-D1-Data-Dictionary_2.pdf
DATANCT00499616-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00499616-D2
Data DictionaryNCT00499616-D2-Data-Dictionary_2.pdf
DATANCT00499616-D2-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00499616-D3
Data DictionaryNCT00499616-D3-Data-Dictionary_2.pdf
DATANCT00499616-D3-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00499616-D4
Data DictionaryNCT00499616-D4-Data-Dictionary_2.pdf
DATANCT00499616-D4-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00499616-D5
Data DictionaryNCT00499616-D5-Data-Dictionary_2.pdf
DATANCT00499616-D5-Dataset_1.csv
OTHERREADME.pdf
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