At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma
In Brief
A Phase 3 clinical trial evaluating Laboratory Biomarker Analysis, Placebo, and 3 other interventions for Clear Cell Renal Cell Carcinoma and 3 related conditions. Completed, enrolled 1,943 participants across 987 sites in 3 countries.
Signals
Detailed Summary
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.
Study Details
Timeline
Arms & Interventions
Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate PO QD for 4 weeks and placebo sorafenib tosylate PO QD or BID for 6 weeks.
Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate PO QD or BID for 6 weeks and placebo sunitinib malate PO QD for 4 weeks followed.
Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate as in Arm A and placebo sunitinib malate as in Arm B.
Interventions
Correlative studies
Given PO
Ancillary studies
Given PO
Given PO