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

This study has been completed.
Sponsor:
Collaborators:
ECOG-ACRIN Cancer Research Group
NCIC Clinical Trials Group
Southwest Oncology Group
Cancer and Leukemia Group B
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00326898
First received: May 16, 2006
Last updated: October 18, 2016
Last verified: October 2016
Results First Received: October 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Stage I Renal Cell Cancer
Stage II Renal Cell Cancer
Stage III Renal Cell Cancer
Interventions: Other: Placebo
Drug: Sorafenib
Drug: Sunitinib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was activated on April 24, 2006 and closed to accrual on September 1, 2010, after accrual of 1943 patients.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm A (Sunitinib + Sorafenib Placebo) Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
Arm B (Sorafenib + Sunitinib Placebo) Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
Arm C (Sunitinib Placebo + Sorafenib Placebo) Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.

Participant Flow:   Overall Study
    Arm A (Sunitinib + Sorafenib Placebo)   Arm B (Sorafenib + Sunitinib Placebo)   Arm C (Sunitinib Placebo + Sorafenib Placebo)
STARTED   647   649   647 
Patients With Toxicity Data   625   628   626 
Patients With Clear Cell Histology   542   540   540 
Patients With >=1 Follow-up MUGA Scan   513   510   580 
COMPLETED   296   306   444 
NOT COMPLETED   351   343   203 
Disease progression                52                54                102 
Adverse Event                124                128                33 
Death                2                0                0 
Withdrawal by Subject                134                128                32 
Alternative therapy                1                0                0 
Other complicating disease                5                5                4 
Other/Missing/Unknown                33                28                32 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized patients

Reporting Groups
  Description
Arm A (Sunitinib + Sorafenib Placebo) Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
Arm B (Sorafenib + Sunitinib Placebo) Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
Arm C (Sunitinib Placebo + Sorafenib Placebo) Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
Total Total of all reporting groups

Baseline Measures
   Arm A (Sunitinib + Sorafenib Placebo)   Arm B (Sorafenib + Sunitinib Placebo)   Arm C (Sunitinib Placebo + Sorafenib Placebo)   Total 
Overall Participants Analyzed 
[Units: Participants]
 647   649   647   1943 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   489   507   500   1496 
>=65 years   158   142   147   447 
Gender 
[Units: Participants]
       
Female   218   212   204   634 
Male   429   437   443   1309 


  Outcome Measures
  Show All Outcome Measures

1.  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 ]

2.  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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Other Pre-specified:   The Association Between Angiogenesis Markers and Disease-free Survival   [ 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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Other Pre-specified:   The Association Between Disease-free Survival and the Frequency of Oncogene as Well as Tumor Suppressor Gene Mutations   [ 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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Other Pre-specified:   The Association Between Tumor and Genetic Polymorphisms and Disease-free Survival   [ 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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Other Pre-specified:   The Association Between DNA Methylation Profiles and Disease-free Survival   [ 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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Other Pre-specified:   The Relationship of Polymorphisms in Drug Metabolizing Enzymes With Steady State Concentrations of Sorafenib and Sunitinib in Selected Patients   [ 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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Other Pre-specified:   The Effect of VEGF Targeted Therapy on Circulating Endothelial Cells and Circulating Endothelial Progenitors   [ 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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Other Pre-specified:   Patient-reported Fatigue Using Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale   [ Time Frame: Assessed at baseline, 10 weeks and 22 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

12.  Other Pre-specified:   Patient-reported Fatigue Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form   [ Time Frame: Assessed at baseline, 10 weeks and 22 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

13.  Other Pre-specified:   The Association Between Scan Frequency and Development of Congestive Heart Failure   [ Time Frame: Assessed at 3, 6 and 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

14.  Other Pre-specified:   Frequency of Clinically Significant Congestive Heart Failure (CHF) Grade 3 or Higher Using the Common Terminology Criteria for Adverse Events Version 4.0   [ Time Frame: Assessed every 6 weeks while on treatment and for 30 days after the end of treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: ECOG-ACRIN Statistical Office
phone: 617-632-3012


Publications of Results:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00326898     History of Changes
Other Study ID Numbers: NCI-2009-00534
NCI-2009-00534 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
E2805 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
U10CA023318 ( US NIH Grant/Contract Award Number )
Study First Received: May 16, 2006
Results First Received: October 18, 2016
Last Updated: October 18, 2016