NCTN: Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor (AREN0532)

Study ID: AREN0532
NCT Numbers: NCT00352534
Children's Oncology Group
Submitted in collaboration with the NCTN/NCORP Data Archive
Trial Title: NCTN: Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor (AREN0532)

Trial Description: This 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, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. 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.
Clinical data presented in the following publication(s):

• PMID 27811504
• PMID 29211618

Disease type(s): Kidney Neoplasm - Wilms Tumor

Clinical Dataset(s) included:

• NCT00352534-D1 (PMID 27811504): There is one dataset (-D1) for the AREN0532 primary publication 27811504, reporting on the trial's very low-risk cohort. This dataset contains baseline characteristics, WT1 mutation status, loss of heterozygosity, relapse sites, presence of intralobar and perilobar rests, survival, secondary malignancy, and radiotherapy type data.
• NCT00352534-D2 (PMID 29211618): There are two datasets (-D2 and -D3) for the AREN0532 primary publication 29211618, reporting on patients with stage III favorable-histology Wilms tumor. There is one row for each patient enrolled. The dataset contains the data for the consort flow of patient enrollment, baseline characteristics, surgery details, 1p/16q loss of heterozygosity status, second malignant neoplasm, survival, relapse site, grade of adverse events, and tumor status data for the patients on AREN0532 as reported in the manuscript.
• NCT00352534-D3 (PMID 29211618): There are two datasets (-D2 and -D3) for the AREN0532 primary publication 29211618, reporting on patients with stage III favorable-histology Wilms tumor. This dataset contains EFS and OS data for patients enrolled on the Q9401 study described in the manuscript to compare outcomes for patients on AREN0532 to similar patients on Q9401 who received the same therapy.

Select data from Q9401 (NCT00002611) used in AREN0532 publication PMID 29211618 are contained in NCT003525234-D3.

You are encouraged to view the PDF data dictionaries found in the “Documents” tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).

• Type: Interventional
• Archive: The database of Genotypes and Phenotypes (dbGaP)