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Type(s) of Cancer
Kidney
Study Phase
Phase 3
Study Completion Date
2016-06-30
NCT00379340Uploaded 08-20-2019
Access via NCI by Request
PDS UID: nci-data-392
Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors
Provider Information
Provider Data DescriptionNCT00379340-D4 These data provide specific incidences of adverse events. ?NCT00379340-D4? is necessary for recreating table A3 in the manuscript. Each row corresponds to a single Adverse Event.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Wilms' tumor. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.
ConditionsStage III Kidney Wilms Tumor
Stage IV Kidney Wilms Tumor
Intervention TypeRadiation: 3-Dimensional Conformal Radiation Therapy
Procedure: Conventional Surgery
Drug: Cyclophosphamide
Biological: Dactinomycin
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Drug: Vincristine Sulfate Liposome
Drug(s)Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Drug: Vincristine Sulfate Liposome
Total Enrolled395
RandomizationNa
Blinding MethodNone
Arms InterventionTreatment (chemotherapy, surgery, radiotherapy) - Experimental
Secondary IDNCI-2009-00419
PubMed (PMID)35580298
31449468
29659330
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Israel
New Zealand
Puerto Rico
Switzerland
Age Range29 Years and younger (CHILD, ADULT)
Files: NCT00379340-D4
Data DictionaryNCT00379340-D4-Data-Dictionary_0.pdf
DATANCT00379340-D4-Dataset_0.csv
OTHERREADME.pdf
Files: NCT00379340-D3
Data DictionaryNCT00379340-D3-Data-Dictionary_0.pdf
DATANCT00379340-D3-Dataset_0.csv
OTHERREADME.pdf
Files: NCT00379340-D2
Data DictionaryNCT00379340-D2-Data-Dictionary_0.pdf
DATANCT00379340-D2-Dataset_0.csv
OTHERREADME.pdf
Files: NCT00379340-D1
Data DictionaryNCT00379340-D1-Data-Dictionary_0.pdf
DATANCT00379340-D1-Dataset_0.csv
OTHERREADME.pdf
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