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Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)
This study is currently recruiting participants.
Verified by Bayer, November 2009
First Received: June 5, 2008   Last Updated: November 23, 2009   History of Changes
Sponsor: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00692770
  Purpose

To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation).


Condition Intervention Phase
Carcinoma, Hepatocellular
Drug: Nexavar (Sorafenib, BAY43-9006)
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase III Randomized, Double-blind, Placebo-controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma After Surgical Resection or Local Ablation.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Recurrence Free Survival [ Time Frame: approximately 40 months from first patient first visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to recurrence [ Time Frame: approximately 40 months from first patient first visit ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 80 months from first patient first visit ] [ Designated as safety issue: No ]
  • Patient-Reported Outcome (PRO) as assessed by FACT-Hep and EQ-5D questionnaire. [ Time Frame: approximately 40 months from first patient first visit ] [ Designated as safety issue: No ]
  • Evaluation of biomarkers. [ Time Frame: approximately 40 months from first patient first visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: August 2008
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Experimental Drug: Nexavar (Sorafenib, BAY43-9006)
400mg (2 x 200mg tablets) orally, twice a day, continuously , until disease recurrence or unacceptable toxicity or other criteria for withdrawal are met.
Arm 2: Placebo Comparator Drug: Placebo
400mg (2 x 200mg tablets) orally, twice a day, continuously , until disease recurrence or unacceptable toxicity or other criteria for withdrawal are met.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have undergone surgical resection or local ablation (PEI or percutaneous or intraoperative RFA) for treatment of HCC with curative intent within 4 months from staging to potentially curative treatment. A maximum of 2 local ablation courses may be administered during this time period.
  • 4 weeks (28 days ± 7 days) from resection or last local ablation course, to CT/MRI scan date
  • Male or female subjects > 18 years of age
  • Confirmation of CR (absence of residual tumor after curative treatment), on the eligibility scan by independent radiological review.
  • For subjects undergoing surgical resection pathology proven complete removal of tumor.
  • Intermediate or High Risk of recurrence as assessed by tumor characteristics.
  • Child-Pugh score 5 -7 points. A Child-Pugh score of 7 points is allowed only in the absence of ascites.
  • ECOG Performance Status of 0.
  • Adequate bone marrow, liver and renal function

Exclusion Criteria:

  • Recurrent HCC
  • Child-Pugh score 7 points with presence of ascites.
  • Low risk of recurrence after curative treatment
  • History of cardiovascular disease
  • History of HIV infection
  • Active clinically serious infections (> grade 2 NCI-CTCAE version 3.0)
  • Subjects with seizure disorder requiring medication (such as steroids or anti-epileptics)
  • Subjects with evidence or history of bleeding diathesis
  • Subjects undergoing renal dialysis
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
  • Uncontrolled ascites (defined as not easily controlled with diuretic treatment)
  • Encephalopathy
  • History of GI bleeding within 30 days.
  • Subjects with a history of esophageal varices bleeding which has not been followed by effective therapy and/or treatment to prevent bleeding recurrence.
  • Prior anti cancer therapy (including sorafenib or any other molecular therapy) is excluded.
  • Major surgery within 4 weeks of start of study, except for surgical resection or local ablation of HCC.
  • Investigational drug therapy outside of this trial during or within 4 weeks of study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692770

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

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Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States, 35294
United States, Arizona
Recruiting
Phoenix, Arizona, United States, 85054-4502
United States, California
Terminated
La Jolla, California, United States, 92093
Recruiting
Los Angeles, California, United States, 90095
Recruiting
Los Angeles, California, United States, 90089
Recruiting
San Francisco, California, United States, 94115
United States, District of Columbia
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Washington, District of Columbia, United States, 20007-2197
United States, Florida
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Miami, Florida, United States, 33136
United States, Georgia
Recruiting
Atlanta, Georgia, United States, 30322
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Atlanta, Georgia, United States, 30309-1231
United States, Illinois
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Maywood, Illinois, United States, 60153
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Chicago, Illinois, United States, 60612-7236
United States, Indiana
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Indianapolis, Indiana, United States, 46202
United States, Kansas
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Kansas City, Kansas, United States, 66160
United States, Kentucky
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Louisville, Kentucky, United States, 40202
United States, Louisiana
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New Orleans, Louisiana, United States, 70112
United States, Maryland
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Baltimore, Maryland, United States, 21287
United States, Massachusetts
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Boston, Massachusetts, United States, 02114-2696
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Burlington, Massachusetts, United States, 01805
United States, Michigan
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Ann Arbor, Michigan, United States, 48109-0330
United States, Minnesota
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Minneapolis, Minnesota, United States, 55455
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Minneapolis, Minnesota, United States, 55407
United States, New York
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New York, New York, United States, 10029
United States, Ohio
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Columbus, Ohio, United States, 43210-1240
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Cleveland, Ohio, United States, 44195
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Cleveland, Ohio, United States, 44106-2602
United States, Oregon
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Portland, Oregon, United States, 97239
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Portland, Oregon, United States, 97213-2967
United States, Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
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Houston, Texas, United States, 77030
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Richmond, Virginia, United States, 23249-0002
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Seattle, Washington, United States, 98109-1023
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Seattle, Washington, United States, 98101
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Madison, Wisconsin, United States, 53792
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Buenos Aires, Capital Federal, Argentina, 1078
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Buenos Aires, Capital Federal, Argentina, C1118AAT
Argentina, Mendoza
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Guaymallen, Mendoza, Argentina, 5519
Argentina, Santa Fe
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Rosario, Santa Fe, Argentina, 2000
Australia, New South Wales
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Camperdown, New South Wales, Australia, 2050
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Randwick, New South Wales, Australia, 2031
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St Leonards, New South Wales, Australia, 2065
Australia, Queensland
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Greenslopes, Queensland, Australia, 4120
Australia, Victoria
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Heidelberg, Victoria, Australia, 3084
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Prahran, Victoria, Australia, 3181
Austria
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Salzburg, Austria, 5020
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Wien, Austria, 1090
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Linz, Oberösterreich, Austria, 4010
Austria, Tirol
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Innsbruck, Tirol, Austria, 6020
Belgium
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Bruxelles, Belgium, 1200
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Liege, Belgium, 4000
Recruiting
Gent, Belgium, 9000
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Leuven, Belgium, 3000
Brazil
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Porto Alegre, Rio Grande do Sul, Brazil, 90619900
Brazil, RS
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Porto Alegre, RS, Brazil
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Porto Alegre, RS, Brazil, 90470 340
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São Paulo, SP, Brazil, 01323-001
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Sao Paulo, SP, Brazil, 05403-900
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Sofia, Bulgaria, 01784
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Sofia, Bulgaria, 1431
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Varna, Bulgaria, 9010
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Plovdiv, Bulgaria, 4004
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4N1
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
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Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
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Toronto, Ontario, Canada, M5G 2M9
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Ottawa, Ontario, Canada, K1H 8L6
Terminated
London, Ontario, Canada, N6A 5A5
Canada, Quebec
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Montreal, Quebec, Canada, H3A 1A1
Chile
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Valparaiso, Chile, 236-3058
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Santiago, Chile, 838-0456
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Viña Del Mar, Chile
Chile, Región Metropolitana
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Santiago de Chile, Región Metropolitana, Chile, 833-0024
China
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Beijing, China, 100071
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Beijing, China, 100036
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Shanghai, China, 200438
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Beijing, China, 100021
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Shanghai, China, 200032
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Tianjin, China
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Beijing, China, 100853
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Chongqing, China, 400038
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Shanghai, China, 200001
China, Anhuii
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Hefei, Anhuii, China, 230022
China, Guangdong
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Guangzhou, Guangdong, China, 510060
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Guangzhou, Guangdong, China, 510515
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Guangzhou, Guangdong, China, 510080
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Guangzhou, Guangdong, China, 510000
China, Guangxi
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Nanning, Guangxi, China, 530021
China, Hubei
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Wuhan, Hubei, China, 430030
China, Hubei province
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Wuhan, Hubei province, China, 430032
China, Hunan
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Changsha, Hunan, China, 410013
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Changsha, Hunan, China, 410013
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Changsha, Hunan, China, 410008
China, Jiangsu
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Nanjing, Jiangsu, China, 210002
China, Liaoning
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Dalian, Liaoning, China, 116027
China, Shan'xi
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Xi'an, Shan'xi, China, 710068
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Xi'an, Shan'xi, China, 710038
China, Shanxi
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Xi'an, Shanxi, China, 710061
China, Sichuan
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Chengdu, Sichuan, China, 610041
China, Zhejiang
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Hangzhou, Zhejiang, China, (310022),
France
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Bondy, France, 93143
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Bordeaux, France, 33000
Recruiting
Vandoeuvre-les-nancy, France, 54500
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Paris, France, 75020
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Lille, France, 59037
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Paris, France, 75012
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Lyon Cedex, France, 69288
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Angers Cedex 01, France, 49033
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Creteil, France, 94010
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Toulouse, France, 31059
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Rennes Cedex, France, 35062
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Villejuif, France, 94800
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Marseille, France, 13005
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Nice, France, 06002
Germany
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Berlin, Germany, 12200
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Hamburg, Germany, 20251
Germany, Baden-Württemberg
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Freiburg, Baden-Württemberg, Germany, 79106
Germany, Bayern
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München, Bayern, Germany, 81675
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Regensburg, Bayern, Germany, 93053
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München, Bayern, Germany, 81377
Germany, Niedersachsen
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Hannover, Niedersachsen, Germany, 30625
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Göttingen, Niedersachsen, Germany, 37075
Germany, Nordrhein-Westfalen
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Düsseldorf, Nordrhein-Westfalen, Germany, 40225
Recruiting
Essen, Nordrhein-Westfalen, Germany, 45147
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Aachen, Nordrhein-Westfalen, Germany, 52074
Recruiting
Köln, Nordrhein-Westfalen, Germany, 50931
Germany, Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, Germany, 55131
Germany, Saarland
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Homburg, Saarland, Germany, 66421
Germany, Sachsen-Anhalt
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Halle, Sachsen-Anhalt, Germany, 06097
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Magdeburg, Sachsen-Anhalt, Germany, 39112
Greece
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Thessaloniki, Greece, 54642
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Larissa, Greece, 41111
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Thessaloniki, Greece, 540 07
Hong Kong
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Hong Kong, Hong Kong
Italy
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Palermo, Italy, 90127
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Milano, Italy, 20133
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Bologna, Italy, 40138
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Milano, Italy, 20121
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Palermo, Italy, 90127
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Benevento, Italy, 82100
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Roma, Italy, 00168
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Roma, Italy, 00189
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Catania, Italy, 95124
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Torino, Italy, 10126
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Bari, Italy, 70124
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Modena, Italy, 41124
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Napoli, Italy, 80131
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Padova, Italy, 35128
Italy, Cagliari
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Selargius, Cagliari, Italy, 09047
Italy, Foggia
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San Giovanni Rotondo, Foggia, Italy, 71013
Japan
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Fukuoka, Japan, 812-8582
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Kumamoto, Japan, 860-8556
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Kyoto, Japan, 606-8507
Recruiting
Okayama, Japan, 700-8558
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Osaka, Japan, 537-8511
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Tokushima, Japan, 770-8503
Japan, Chiba
Recruiting
Kashiwa, Chiba, Japan, 277-8577
Japan, Ishikawa
Recruiting
Kanazawa, Ishikawa, Japan, 920-8641
Japan, Kanagawa
Terminated
Kawasaki, Kanagawa, Japan, 213-8587
Recruiting
Yokohama, Kanagawa, Japan, 232¿0024
Japan, Osaka
Recruiting
Osakasayama, Osaka, Japan, 589-8511
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Suita, Osaka, Japan, 565-0871
Japan, Tokyo
Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Recruiting
Shibuya-ku, Tokyo, Japan, 150-8935
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Itabashi-ku, Tokyo, Japan, 173-8610
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Shinjuku-ku, Tokyo, Japan, 162-8666
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Bunkyo-ku, Tokyo, Japan, 113-8655
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Minato-ku, Tokyo, Japan, 105-8470
Korea, Republic of
Recruiting
Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 138-736
Recruiting
Seoul, Korea, Republic of, 120-752
Recruiting
Seoul, Korea, Republic of, 135-710
Recruiting
Gyeonggi-do, Korea, Republic of, 410-769
Recruiting
Seoul, Korea, Republic of
Recruiting
Pusan, Korea, Republic of, 602 739
Not yet recruiting
Ask Contact, Korea, Republic of, 561-712
Recruiting
Daegu, Korea, Republic of, 702-701
Korea, Republic of, South Korea
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Goyang-si, South Korea, Korea, Republic of, 411-706
Mexico
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México, D.f., Mexico, 14050
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México, D.f., Mexico, 14080
Mexico, Nueva León
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Monterrey, Nueva León, Mexico, 64710
New Zealand
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Christchurch, New Zealand, 8011
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Auckland, New Zealand, 1023
Peru
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Lima, Peru, LIMA 11
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San Borja, Peru
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Chiclayo, Peru, CIX
Portugal
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Coimbra, Portugal, 3000-076
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Lisboa, Portugal, 1069-166
Romania
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Bucharest, Romania, 11172
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Cluj-Napoca, Romania, 400015
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Bucharest, Romania
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Iasi, Romania
Romania, Iasi county
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Iasi, Iasi county, Romania, 700111
Russian Federation
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Voronezh, Russian Federation, 394000
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Moscow, Russian Federation, 115478
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Moscow, Russian Federation, 119992
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Moscow, Russian Federation, 115478
Recruiting
St. Petersburg, Russian Federation, 197758
Russian Federation, Kaluga region
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Obninsk, Kaluga region, Russian Federation, 249036
Singapore
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Singapore, Singapore, 169608
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Singapore, Singapore, 119074
Spain
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A Coruña, Spain, 15006
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Badajoz, Spain, 06080
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Barcelona, Spain, 08036
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Barcelona, Spain, 08035
Recruiting
Valladolid, Spain, 47010
Recruiting
Madrid, Spain, 28040
Recruiting
Madrid, Spain, 28007
Recruiting
Córdoba, Spain, 14004
Spain, Asturias
Recruiting
Oviedo, Asturias, Spain, 33006
Spain, Barcelona
Recruiting
Sabadell, Barcelona, Spain, 08208
Spain, Bizkaia
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Barakaldo, Bizkaia, Spain, 48903
Spain, Madrid
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Majadahonda, Madrid, Spain, 28222
Sweden
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Stockholm, Sweden, 171 76
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Göteborg, Sweden, 413 45
Switzerland
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Bern, Switzerland, 3010
Recruiting
Zürich, Switzerland, 8091
Taiwan
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Changhua, Taiwan, 500
Recruiting
Taipei, Taiwan, 100
Recruiting
Taipei, Taiwan, 112
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Kaohsiung, Taiwan, 833
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Kaohsiung, Taiwan, 80756
United Kingdom, Greater London
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London, Greater London, United Kingdom, NW3 2QG
Recruiting
London, Greater London, United Kingdom, SE5 9RS
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London, Greater London, United Kingdom, EC1A 7BE
United Kingdom, Greater Manchester
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Manchester, Greater Manchester, United Kingdom, M20 4BX
United Kingdom, Hampshire
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Southampton, Hampshire, United Kingdom, SO16 6YD
United Kingdom, Tyne and Wear
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Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
United Kingdom, West Midlands
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Birmingham, West Midlands, United Kingdom, B15 2TT
United Kingdom, West Yorkshire
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Leeds, West Yorkshire, United Kingdom, LS9 7TF
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers: 12414, 2008-001087-36, STORM
Study First Received: June 5, 2008
Last Updated: November 23, 2009
ClinicalTrials.gov Identifier: NCT00692770     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Hepatocellular,
Sorafenib,
Adjuvant,
Surgical resection,
Ablation

Additional relevant MeSH terms:
Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Carcinoma, Hepatocellular
Physiological Effects of Drugs
Adjuvants, Immunologic
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Liver Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 30, 2009