Type(s) of Cancer
Neuroblastoma
Neuroblastoma
Study Phase
Phase 3
Study Completion Date
2015-02-27
2015-02-27
NCT00567567Uploaded 09-29-2020
Access via NCI by Request
PDS UID: nci-data-428
Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma
Provider Information
Provider Data DescriptionThere is one dataset associated with the publication: NCT00567567-D1.
USI is the patient identifier and blanks or "." 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).
NCT00567567-D1: There is one row for each patient enrolled on the study ANBL0532. The dataset provides the information necessary to reproduce the manuscript.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial compares two different high-dose chemotherapy regimens followed by a stem cell transplant in treating younger patients with high-risk neuroblastoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments before a peripheral blood stem cell transplant helps kill any tumor cells that are in the body and helps make room in the patient?s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. High-dose chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the high- chemotherapy. It is not yet known which regimen of high-dose chemotherapy is more effective for patients with high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.
ConditionsLocalized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Recurrent Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
Stage 4S Neuroblastoma
Localized Unresectable Neuroblastoma
Recurrent Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
Stage 4S Neuroblastoma
Intervention TypeProcedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Radiation: External Beam Radiation Therapy
Biological: Filgrastim
Drug: Isotretinoin
Other: Laboratory Biomarker Analysis
Drug: Melphalan
Procedure: Peripheral Blood Stem Cell Transplantation
Other: Pharmacological Study
Drug: Thiotepa
Drug: Topotecan Hydrochloride
Drug: Vincristine Sulfate Liposome
Drug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Radiation: External Beam Radiation Therapy
Biological: Filgrastim
Drug: Isotretinoin
Other: Laboratory Biomarker Analysis
Drug: Melphalan
Procedure: Peripheral Blood Stem Cell Transplantation
Other: Pharmacological Study
Drug: Thiotepa
Drug: Topotecan Hydrochloride
Drug: Vincristine Sulfate Liposome
Drug(s)Drug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Drug: Isotretinoin
Drug: Melphalan
Drug: Topotecan Hydrochloride
Drug: Vincristine Sulfate Liposome
Drug: Thiotepa
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Drug: Isotretinoin
Drug: Melphalan
Drug: Topotecan Hydrochloride
Drug: Vincristine Sulfate Liposome
Drug: Thiotepa
Total Enrolled665
RandomizationRandomized
Blinding MethodNone
Arms InterventionConsolidation Arm A: single myeloablative consolidation - Active Comparator
Consolidation Arm B: tandem myeloablative consolidation - Experimental
Consolidation Arm B: tandem myeloablative consolidation - Experimental
Secondary IDNCI-2009-01065
PubMed (PMID)32530765
31454045
31454045
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
New Zealand
Puerto Rico
Switzerland
Australia
Canada
New Zealand
Puerto Rico
Switzerland
Age Range30 Years and younger (CHILD, ADULT)
Files: NCT00567567-D1
Data DictionaryNCT00567567-D1-Data-Dictionary_2.pdf
DATANCT00567567-D1-Dataset_3.csv
OTHERREADME.pdf
