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NCTN: ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma (E2805)

Study ID: E2805

NCT Number: NCT00326898

ECOG-ACRIN Cancer Research Group

Submitted in collaboration with the NCTN/NCORP Data Archive

Trial Title: NCTN: ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma (E2805)

Trial Description: This randomized phase III trial studies sunitinib malate to see how well it works compared to sorafenib tosylate or placebo in treating patients with kidney cancer that has been removed by surgery. Sunitinib malate and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate or sorafenib tosylate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib malate is more effective than sorafenib tosylate or placebo in treating kidney cancer.

Clinical data presented in the following publication(s):

• PMID 26969090

• PMID 30130544

• PMID 31471309

• Additional unpublished data from E2805

Disease type(s): Kidney Neoplasm - Renal Cell Carcinoma

Clinical Dataset(s) included:

• NCT00326898-D1 (PMID 26969090): There are two datasets for E2805's primary publication 26969090 (-D1 and -D2). This dataset, NCT00326898-D1, contains baseline characteristics, stratification factors, treatment dose, number of cycles received, surgery type (radical or partial nephrectomy), and outcome data. Patient ID 1410 corresponds to a duplicate registration for which no data was collected and therefore excluded. NCT00326898-D2 contains toxicity data. Patients in the NCT00326898-D1 through -D7 datasets have the same deidentified patient IDs.

• NCT00326898-D2 (PMID 26969090): There are two datasets for E2805's primary publication 26969090 (-D1 and -D2). This dataset, NCT00326898-D2, contains toxicity data. NCT00326898-D1 contains baseline characteristics, stratification factors, treatment dose, number of cycles received, surgery type (radical or partial nephrectomy), and outcome data. Patients in the NCT00326898-D1 through -D7 datasets have the same deidentified patient IDs.

• NCT00326898-D3 (Unpublished data): This dataset, NCT00326898-D3, contains data collected on ECOG-ACRIN trial E2805, which are not published in the primary, nonclear cell renal cell carcinoma cohort, or cytokine analysis publication for the trial. NCT00326898-D3 includes information on arm A (Sunitinib) and arm B (Sorafenib) patients that started treatment for E2805 study. The dataset contains information on the time interval from randomization to treatment start date, treatment dose, and reasons for dose modification by cycle. Treatment arm information can be found in D1. Patients in the NCT00326898-D1 through -D7 datasets have the same deidentified patient IDs.

• NCT00326898-D4 (Unpublished data): This dataset, NCT00326898-D4, contains data collected on ECOG-ACRIN trial E2805, which are not published in the primary, nonclear cell renal cell carcinoma cohort, or cytokine analysis publication for the trial. NCT00326898-D4 contains toxicity data (by cycle) on hypertension, diarrhea, hand-foot reaction, and/or rash/desquamation while on treatment for E2805 study, including treatment attribution and time interval from randomization to toxicity start date. Patients in the NCT00326898-D1 through -D7 datasets have the same deidentified patient IDs. Treatment arm information can be found in D1.

• NCT00326898-D5 (PMID 30130544): There is one dataset for PMID 30130544 (-D5). This dataset, NCT00326898-D5, contains the analysis data published in PMID 30130544, a publication focusing on the nonccRCC subgroup of ECOG-ACRIN trial E2805. This dataset contains recurrence site data, competing risk indicators, and updated survival times. Variables reported in this publication such as age, sex, treatment arm, and histology are identical to those presented in NCT00326898-D1 (for the trial's primary publication, PMID 26969090) and are thus not duplicated in this dataset. NCT00326898-D5 can be used together with the NCT00326898-D6 dataset to obtain updated, complete information on sites of recurrence. Patients in the NCT00326898-D1 through -D7 datasets have the same deidentified patient IDs.

• NCT00326898-D6 (Unpublished data): This dataset, NCT00326898-D6, contains data collected on ECOG-ACRIN trial E2805, which are not published in the primary, nonclear cell renal cell carcinoma cohort, or cytokine analysis publication for the trial. NCT00326898-D6 contains information (the time interval from nephrectomy to randomisation, cause of death, histology components, and clarification about what sites the "other" and "other organs" (-D5) include for sites of recurrence) collected on the trial but not published. Both NCT00326898-D5 and NCT00326898-D6 datasets together provide updated, complete information on sites of recurrence. Patients in the NCT00326898-D1 through -D7 datasets have the same deidentified patient IDs. COD data is consistent with survival information presented in D5.

• NCT00326898-D7 (PMID 31471309): There is one dataset for PMID 31471309 (-D7). This dataset contains the cytokine analysis data published in PMID 31471309 based on trial NCT00326898. Variables reported in this publication such as treatment arm, T-stage, Fuhrman grade, ECOG PS, DFS, and DFS event are identical to those presented in NCT00326898-D1 (for the trial's primary publication, PMID 26969090) and are thus not duplicated in this dataset.

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).