Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery

Study acronym: ASSURE
StatusCompleted
PhasePhase 3
Started

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Record History

The 50 most recent of 1051 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv1051
  2. Primary completion date: Dec 29, 2010 to Aug 27, 2015
    • Study completion date: Aug 27, 2015 to Sep 1, 2021
    v1050
  3. Re-verified, no change to tracked fieldsv1049
  4. Study sites: 921 to 987v1048 Show 8 more changesShow less
    • Primary completion date: Dec 2010 to Dec 29, 2010
    • Study completion date: Aug 2015 to Aug 27, 2015
    • Start date: Apr 2006 to Apr 24, 2006
    • Interventions: Placebo (Other), Sorafenib (Drug), Sunitinib (Drug) to Laboratory Biomarker Analysis (Other), Placebo (Other), Quality-of-Life Assessment (Other), Sorafenib Tosylate (Drug), Sunitinib Malate…
    • Eligibility criteria expanded, about 55 words
    • Study description shortened, about 18 words
    • Collaborators: 4 to 3
    • Publications: 8 to 7
  5. Site details revised at 2 of 921 sitesv1047
Show 45 earlier versionsHide 45 earlier versions
  1. Secondary endpoints: details revised at 1 of 3 entriesv1046
  2. Results first posted: Dec 12, 2016v1045 Show 8 more changesShow less
    • Enrollment target: 1877 to 1943
    • Interventions: Laboratory Biomarker Analysis (Other), Placebo (Other), Quality-of-Life Assessment (Other), Sorafenib Tosylate (Drug), Sunitinib Malate… to Placebo (Other), Sorafenib (Drug), Sunitinib (Drug)
    • Eligibility criteria shortened, about 55 words
    • Secondary endpoints: 7 to 3
    • Primary endpoint revised
    • Study description expanded, about 18 words
    • Collaborators: 3 to 4
    • Publications: 7 to 8
  3. Trial status: Active, Not Recruiting to Completedv1044 Show 4 more changesShow less
    • Enrollment target: estimated 1923 to confirmed 1877
    • Primary completion date changed from estimate of Apr 2016 to Dec 2010
    • Study completion date: Aug 2015
    • Study sites revised (921)
  4. Study sites revised (921)v1043
  5. Study sites revised (921)v1042
  6. 12 versions Re-verified since Apr 12, 2016, no change to tracked fieldsv1030-v1041
  7. Site details revised at 1 of 921 sitesv1029
  8. 2 versions Re-verified since Apr 7, 2016, no change to tracked fieldsv1027-v1028
  9. Site details revised at 1 of 921 sitesv1026
  10. 2 versions Re-verified since Apr 4, 2016, no change to tracked fieldsv1024-v1025
  11. Study sites revised (921)v1023
  12. 2 versions Re-verified since Mar 30, 2016, no change to tracked fieldsv1021-v1022
  13. Study sites revised (921)v1020
  14. 4 versions Re-verified since Mar 23, 2016, no change to tracked fieldsv1016-v1019
  15. Study sites revised (921)
    • Collaborators revised (3)
    v1015
  16. Re-verified, no change to tracked fieldsv1014
  17. Collaborators revised (3)v1013
  18. 3 versions Re-verified since Mar 15, 2016, no change to tracked fieldsv1010-v1012
  19. Study sites revised (921)v1009
  20. Study sites revised (921)v1008
  21. 4 versions Re-verified since Mar 7, 2016, no change to tracked fieldsv1004-v1007
  22. Study sites revised (921)v1003
  23. Re-verified, no change to tracked fieldsv1002
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00326898
Lead Sponsor National Cancer Institute (NCI)
Collaborators: Cancer and Leukemia Group B, NCIC Clinical Trials Group, SWOG Cancer Research Network
Conditions
(from sponsor)		 Clear Cell Renal Cell Carcinoma, Stage I Renal Cell Cancer AJCC v6 and v7, Stage II Renal Cell Cancer AJCC v7, Stage III Renal Cell Cancer AJCC v7
Related terms Carcinoma, Renal Cell
Enrollment 1,943 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov