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Type(s) of Cancer
Kidney
Study Phase
Phase 3
Study Completion Date
December 2016
NCT00945009Uploaded 07-10-2019
Access via NCI by Request
PDS UID - nci-data-389
Treatment for Patients With Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor
Provider Information
Provider Data DescriptionThere is one dataset associated with this publication. This dataset is associated with the manuscript titled, ?Results of the first Prospective Multi-Institutional Treatment Study in Children with Bilateral Wilms Tumor (AREN0534): A report from the Children's Oncology Group.?
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Partial set or SubsetN/A
Patients in dataset249
# of Patients Control0
# of Patients ExperimentalNA
DOIN/A
CDISC StandardNon-SDTM
Study ArmsUndefined
Clinical Trials.gov Information
Brief SummaryThis phase III trial studies how well combination chemotherapy and surgery work in treating young patients with Wilms tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.
ConditionsAdult Kidney Wilms Tumor
Beckwith-Wiedemann Syndrome
Childhood Kidney Wilms Tumor
Diffuse Hyperplastic Perilobar Nephroblastomatosis
Hemihypertrophy
Rhabdoid Tumor of the Kidney
Stage I Kidney Wilms Tumor
Stage II Kidney Wilms Tumor
Stage III Kidney Wilms Tumor
Stage IV Kidney Wilms Tumor
Stage V Kidney Wilms Tumor
Intervention TypeBiological: Dactinomycin
Drug: Doxorubicin Hydrochloride
Radiation: Radiation Therapy
Procedure: Therapeutic Conventional Surgery
Drug: Vincristine Sulfate
Drug(s)Drug: Doxorubicin Hydrochloride
Drug: Vincristine Sulfate
Total Enrolled249
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionArm 1 (Bilateral Wilms Tumors) - Experimental
Arm 2 (Unilateral High Risk tumors bilaterally predisposed) - Experimental
Arm 3 (DHPLN) - Experimental
Secondary IDNCI-2011-01953
PubMed (PMID)NA
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Israel
New Zealand
Puerto Rico
Age RangeMinimum Age: NA
Maximum Age: 29 Years
Files: NCT00945009-D1
Data DictionaryNCT00945009-D1-Data-Dictionary_2.pdf
DATANCT00945009-D1-Dataset_1.csv
OTHERREADME.pdf
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