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Type(s) of Cancer
Kidney
Study Phase
Phase 3
Study Completion Date
December 2014
NCT00352534Uploaded 09-24-2020
Access via NCI by Request
PDS UID: nci-data-427
Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor
Provider Information
Provider Data DescriptionNCT00352534-D1 This dataset is associated with the manuscript titled, ?Clinical Outcome and Biological Predictors of Relapse After Nephrectomy Only for Very Low-risk Wilms Tumor: A Report From Children's Oncology Group AREN0532.?
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor. Drugs used in chemotherapy, such as vincristine, dactinomycin, and doxorubicin, 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 these treatments after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.
ConditionsStage I Kidney Wilms Tumor
Stage II Kidney Wilms Tumor
Stage III Kidney Wilms Tumor
Intervention TypeRadiation: 3-Dimensional Conformal Radiation Therapy
Biological: Dactinomycin
Drug: Doxorubicin Hydrochloride
Procedure: Therapeutic Conventional Surgery
Drug: Vincristine Sulfate
Drug(s)Drug: Doxorubicin Hydrochloride
Drug: Vincristine Sulfate
Total Enrolled808
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionStratum I (very low-risk disease) - Experimental
Stratum II (standard-risk, stage I or II) - Experimental
Stratum III (standard-risk, stage III) - Experimental
Secondary IDNCI-2009-01067
PubMed (PMID)31449468
29211618
27811504
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: NCT00352534-D1
Data DictionaryNCT00352534-D1-Data-Dictionary_6.pdf
DATANCT00352534-D1-Dataset_5.csv
OTHERREADME.pdf
Files: NCT00352534-D2
Data DictionaryNCT00352534-D2-Data-Dictionary_7.pdf
DATANCT00352534-D2-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00352534-D3
Data DictionaryNCT00352534-D3-Data-Dictionary_4.pdf
DATANCT00352534-D3-Dataset_3.csv
OTHERREADME.pdf
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