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Type(s) of Cancer
Kidney
Study Phase
Phase 3
Study Completion Date
June 2002
NCT00002611Uploaded 02-24-2021
Access via NCI by Request
PDS UID: nci-data-456
NATIONAL WILMS TUMOR STUDY-5 -- THERAPEUTIC TRIAL AND BIOLOGY STUDY
Provider Information
Provider Data DescriptionThere are five data submissions associated with PMID 30255545: NCT00002611-D1 through -D5. This dataset, NCT00002611-D1, is used to create the main results of the NWTS 5 study.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. It is not yet known whether combination chemotherapy alone or combination chemotherapy plus radiation therapy is more effective for childhood kidney cancer. PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating children who have kidney cancer.
ConditionsKidney Cancer
Intervention TypeBiological: dactinomycin
Biological: filgrastim
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: vincristine sulfate
Procedure: conventional surgery
Radiation: radiation therapy
Drug(s)Drug: vincristine sulfate
Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Drug: etoposide
Total Enrolled3031
RandomizationN/A
Blinding MethodN/A
Arms InterventionStratum 1 - Active Comparator
Stratum 2 - Active Comparator
Stratum 3 - Active Comparator
Stratum 4 - Active Comparator
Stratum 5 - Active Comparator
Stratum 6 - Active Comparator
Stratum 7 - Active Comparator
Stratum 8 - Active Comparator
Stratum 9 - Active Comparator
Secondary IDCOG-Q9401
PubMed (PMID)22422736
22498384
21683387
20457352
19730241
18778996
18095319
16700047
15590168
22952427
21189373
18989885
19208794
17539021
16710034
16410127
16172460
15868587
16129848
15654272
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Netherlands
New Zealand
Puerto Rico
Switzerland
Age Range0 Years to 15 Years (Child)
Files: NCT00002611-D1
Data DictionaryNCT00002611-D1-Data-Dictionary_2.pdf
DATANCT00002611-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00002611-D2
Data DictionaryNCT00002611-D2-Data-Dictionary_2.pdf
DATANCT00002611-D2-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00002611-D3
Data DictionaryNCT00002611-D3-Data-Dictionary_3.pdf
DATANCT00002611-D3-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00002611-D4
Data DictionaryNCT00002611-D4-Data-Dictionary_2.pdf
DATANCT00002611-D4-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00002611-D5
Data DictionaryNCT00002611-D5-Data-Dictionary_2.pdf
DATANCT00002611-D5-Dataset_2.csv
OTHERREADME.pdf
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