Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00692770
First received: June 5, 2008
Last updated: December 12, 2014
Last verified: December 2014
Results First Received: November 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Carcinoma, Hepatocellular
Interventions: Drug: Nexavar (Sorafenib, BAY43-9006)
Drug: Placebo

  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
Participant recruitment period was between 15 August 2008 to 12 November 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 1602 participants who were screened for inclusion in the study, 1114 were enrolled, and 1107 received treatment.

Reporting Groups
  Description
Sorafenib (Nexavar, BAY43-9006) Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
Placebo Participants received 2 tablets of placebo orally twice daily (BID)

Participant Flow:   Overall Study
    Sorafenib (Nexavar, BAY43-9006)     Placebo  
STARTED     556     558  
Participants Received Treatment     553     554  
COMPLETED     82     107  
NOT COMPLETED     474     451  
Protocol Violation                 2                 7  
Withdrawal by Subject                 93                 35  
Adverse Event                 133                 41  
Death                 10                 5  
Lost to Follow-up                 7                 3  
Non-compliant with study medication                 11                 5  
Randomized but not treated                 3                 4  
Progression by clinical judgment                 2                 3  
Physician decision not protocol driven                 2                 1  
Disease progression, recurrence/relapse                 165                 274  
Protocol driven decision point                 3                 0  
Completed all planned assessments                 35                 65  
Radiological and clinical progression                 8                 8  



  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.
No text entered.

Reporting Groups
  Description
Sorafenib (Nexavar, BAY43-9006) Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
Placebo Participants received 2 tablets of placebo orally twice daily (BID)
Total Total of all reporting groups

Baseline Measures
    Sorafenib (Nexavar, BAY43-9006)     Placebo     Total  
Number of Participants  
[units: participants]
  556     558     1114  
Age  
[units: Years]
Mean ± Standard Deviation
  58.1  ± 11.7     58.7  ± 12.2     58.4  ± 12.0  
Age, Customized  
[units: Participants]
     
<18 years     0     0     0  
Between 18 and 65 years     383     361     744  
>=65 years     173     197     370  
Gender  
[units: Participants]
     
Female     105     97     202  
Male     451     461     912  



  Outcome Measures
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1.  Primary:   Recurrence Free Survival (RFS) by Independent Assessment   [ Time Frame: From randomization up to 4 years or until disease recurrence whichever came first ]

2.  Secondary:   Time to Recurrence (TTR) by Independent Assessment   [ Time Frame: From randomization up to 4 years or until disease recurrence whichever came first ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: From randomization of the first subject until 4 years later. ]

4.  Other Pre-specified:   Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Index Score   [ Time Frame: Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit ]

5.  Other Pre-specified:   Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Visual Analogue Scale (VAS) Score   [ Time Frame: Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit ]

6.  Other Pre-specified:   Patient Reported Outcomes: Functional Assessment of Cancer Therapy (FACT)- Hepatobiliary Subscale (HEP) Score   [ Time Frame: Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit ]

7.  Other Pre-specified:   Patient Reported Outcomes: Functional Assessment of Cancer Therapy (FACT)- General (G) Total Score   [ Time Frame: Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit ]

8.  Other Pre-specified:   Biomarker Analysis   [ Time Frame: From randomization up to 4 years or until disease recurrence whichever came first ]
Results not yet reported.   Anticipated Reporting Date:   12/2015   Safety Issue:   No


  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
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  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 less than or equal to 60 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: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


No publications provided by Bayer

Publications automatically indexed to this study:

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00692770     History of Changes
Other Study ID Numbers: 12414, 2008-001087-36
Study First Received: June 5, 2008
Results First Received: November 24, 2014
Last Updated: December 12, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Chile: Instituto de Salud Pública de Chile
Mexico: Federal Commission for Sanitary Risks Protection
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Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Bulgaria: Bulgarian Drug Agency
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Germany: German Institute of Medical Documentation and Information
Greece: Ethics Committee
Italy: The Italian Medicines Agency
Romania: National Medicines Agency
Russia: Ethics Committee
Switzerland: Swissmedic
Sweden: Ethikkommission
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
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Japan: National Institute of Health Sciences
Hong Kong: Department of Health
Korea: Food and Drug Administration
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Singapore: Health Sciences Authority
Taiwan: Department of Health
United States: Food and Drug Administration