NCT00326898

Clinical Trial Information


Trial Number: NCT00326898 (ClinicalTrials.gov)
Disease Type:
  • Kidney Neoplasm - Renal Cell Carcinoma
Trial Title:
ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma
Study ID:
E2805
Images are available?:
No
Is this a NCI-MATCH Trial?:
No


Datasets Linked to Trial

Title Description
NCT00326898-D9 This dataset, NCT00326898-D9, contains toxicity data (by cycle) on hypertension, diarrhea, hand-foot reaction, and/or rash/desquamation while on treatment for E2805 study. NCT00326898-D8 contains information on the time interval from randomization to treatment start date, treatment dose and reasons for dose modification by cycle. Data in both NCT00326898-D8 and -D9 datasets were collected on the trial but not published. Patients in the NCT00326898-D3, -D4, -D8, and –D9 data submissions have the same deidentified patient IDs.
NCT00326898-D8 This dataset, NCT00326898-D8, contains information on the time interval from randomization to treatment start date, treatment dose and reasons for dose modification by cycle. NCT00326898-D9 contains toxicity data (by cycle) on hypertension, diarrhea, hand-foot reaction, and/or rash/desquamation while on treatment for E2805 study. Data in both NCT00326898-D8 and -D9 datasets were collected on the trial but not published. Patients in the NCT00326898-D3, -D4, -D8, and –D9 data submissions have the same deidentified patient IDs.
NCT00326898-D7 This dataset, NCT00326898-D7, contains information (the time interval from nephrectomy to randomisation, cause of death, histology components, and clarification about what sites the “other” and “other organs” include for sites of recurrence) collected on the trial but not published. NCT00326898-D5 contains data from E2805’s secondary publication, PMID 30130544. Both NCT00326898-D5 and NCT00326898-D7 datasets together provide updated, complete information on sites of recurrence. Patients in the NCT00326898-D5 and –D7 data submissions have the same deidentified patient IDs.
NCT00326898-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. Variables reported in this publication such as age, sex, treatment arm, histology are identical to those presented in NCT00326898-D3 (for the trial’s primary publication, PMID 26969090) and are thus not duplicated in this submission.

NCT00326898-D7 contains information collected on the trial but not published. NCT00326898-D5 can be used together with NCT00326898-D7 datasets to obtain updated, complete information on sites of recurrence.

Patients in the NCT00326898-D5 and –D7 data submissions have the same deidentified patient IDs.
NCT00326898-D4 As of November 6, 2017, there are four different datasets available for NCT00326898. This is NCT00326898-D4. NCT00326898-D1 and NCT00326898-D3 each contain the same clinical data. NCT00326898-D2 and NCT00326898-D4 each contain the same toxicity data. NCT00326898-D1 and NCT00326898-D2 were the original two submissions. NCT00326898-D3 and NCT00326898-D4 updated the original data submissions to include a new blinded ID that will allow for the future linking to non-clinical data (e.g., genomic data). Other than the IDs, the datasets are identical. We recommend that NCT00326898-D3 and NCT00326898-D4 be used.
NCT00326898-D3 As of November 6, 2017, there are four different datasets available for NCT00326898. This is NCT00326898-D3. NCT00326898-D1 and NCT00326898-D3 each contain the same clinical data. NCT00326898-D2 and NCT00326898-D4 each contain the same toxicity data. NCT00326898-D1 and NCT00326898-D2 were the original two submissions. NCT00326898-D3 and NCT00326898-D4 updated the original data submissions to include a new blinded ID that will allow for the future linking to non-clinical data (e.g., genomic data). Other than the IDs, the datasets are identical. We recommend that NCT00326898-D3 and NCT00326898-D4 be used.
NCT00326898-D2 As of November 6, 2017, there are four different datasets available for NCT00326898. This is NCT00326898-D2. NCT00326898-D1 and NCT00326898-D3 each contain the same clinical data. NCT00326898-D2 and NCT00326898-D4 each contain the same toxicity data. NCT00326898-D1 and NCT00326898-D2 were the original two submissions. NCT00326898-D3 and NCT00326898-D4 updated the original data submissions to include a new blinded ID that will allow for the future linking to non-clinical data (e.g., genomic data). Other than the IDs, the datasets are identical. We recommend that NCT00326898-D3 and NCT00326898-D4 be used.
NCT00326898-D1 As of November 6, 2017, there are four different datasets available for NCT00326898. This is NCT00326898-D1. NCT00326898-D1 and NCT00326898-D3 each contain the same clinical data. NCT00326898-D2 and NCT00326898-D4 each contain the same toxicity data. NCT00326898-D1 and NCT00326898-D2 were the original two submissions. NCT00326898-D3 and NCT00326898-D4 updated the original data submissions to include a new blinded ID that will allow for the future linking to non-clinical data (e.g., genomic data). Other than the IDs, the datasets are identical. We recommend that NCT00326898-D3 and NCT00326898-D4 be used.