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Kidney

ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

Unique Data Set IDnci-data-24
DownloadableNo
SponsorNational Cancer InstituteData ProviderNCITotal Study Enrolled Patients1943RandomizationYesPubMed (PMID)26969090.00ClinicalTrial.gov IDNCT00326898ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00326898
Study PhaseClinical Study Phase IIIBlinding MethodOtherType(s) of dataN/AIntervention TypeDrug, PlaceboData Set TypeOther

Clinical Trial Title

ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

Trial Summary and Conditions

This randomized phase III trial studies sunitinib malate and sorafenib tosylate to see how well they work compared to 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 or sorafenib tosylate is more effective than placebo in treating kidney cancer.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To demonstrate an improvement in disease-free survival in locally advanced renal cell carcinoma patients randomly assigned to adjuvant sunitinib (sunitinib malate) (Arm A) or sorafenib (sorafenib tosylate) (Arm B) versus placebo (Arm C) after radical or partial nephrectomy. SECONDARY OBJECTIVES: I. To compare overall survival of patients randomized to each of the two regimens with placebo. II. To further define the toxicity of prolonged administration of sunitinib or sorafenib in this patient population. III. To evaluate cardiac function in each arm OTHER PRE-SPECIFIED OBJECTIVES: I. To prospectively collect tumor and biological specimens to assess their characteristics and associations: novel approaches to assess angiogenesis markers in tissue, blood and urine as predictors of disease-free survival and of therapeutic benefit. II. To prospectively collect tumor and biological specimens to assess their characteristics and associations: the frequency of oncogene and tumor suppressor gene mutations as predictors of disease-free survival and therapeutic benefit. III. To prospectively collect tumor and biological specimens to assess their characteristics and associations: tumor and genetic polymorphisms as predictors of disease-free survival and therapeutic benefit. IV. To prospectively collect tumor and biological specimens to assess their characteristics and associations: deoxyribonucleic acid (DNA) methylation profiles as predictors of outcome and of therapeutic benefit. V. To prospectively collect tumor and biological specimens to assess their characteristics and associations: The relationship of polymorphisms in drug metabolizing enzymes with steady state concentrations of sorafenib and sunitinib in selected patients. VI. To study the effect of vascular endothelial growth factor (VEGF) targeted therapy on circulating endothelial cells and circulating endothelial progenitors.

Outcome Measures

Primary: Disease-free Survival (DFS) [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry ] Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation. Secondary: 5-year Overall Survival Rate [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry ] Proportion of Patients With Cardiac Events [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry ] 5-year Disease-free Survival (DFS) Rate Among Patients With Clear Cell Histology [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry ]

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

Available Downloads:

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00326898-D2-Data-Dictionary.pdf

DATA: NCT00326898-D2-Dataset.csv

OTHER: README.pdf