check_circleStudy Completed
Carcinoma, Hepatocellular
Bayer Identifier:
12414
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)
Trial 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).
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
1114Trial Dates
August 2008 - November 2014Phase
Phase 3Could I Receive a placebo
YesProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | Freiburg, 79106, Germany | |
Completed | München, 81675, Germany | |
Completed | Berlin, 12200, Germany | |
Completed | Aachen, 52074, Germany | |
Completed | Regensburg, 93042, Germany | |
Completed | Göttingen, 37075, Germany | |
Completed | London, NW3 2QG, United Kingdom | |
Completed | Birmingham, B15 2TT, United Kingdom | |
Completed | Southampton, SO16 6YD, United Kingdom | |
Completed | Leeds, LS9 7TF, United Kingdom | |
Completed | Newcastle Upon Tyne, NE7 7DN, United Kingdom | |
Completed | New York, 10029, United States | |
Completed | Miami, 33136, United States | |
Completed | Indianapolis, 46202, United States | |
Completed | Hamburg, 20246, Germany | |
Completed | Halle/Saale, 06120, Germany | |
Completed | Düsseldorf, 40225, Germany | |
Completed | Mainz, 55131, Germany | |
Completed | Essen, 45147, Germany | |
Completed | Hannover, 30625, Germany | |
Completed | Magdeburg, 39120, Germany | |
Completed | Köln, 50937, Germany | |
Completed | Homburg/Saar, 66421, Germany | |
Completed | München, 81377, Germany | |
Completed | London, SE5 9RS, United Kingdom | |
Withdrawn | London, EC1M 6BQ, United Kingdom | |
Completed | Manchester, M20 4BX, United Kingdom | |
Completed | Washington, 20007, United States | |
Completed | Los Angeles, 90033, United States | |
Completed | Minneapolis, 55455, United States | |
Completed | Phoenix, 85054, United States | |
Terminated | Providence Portland Medical Center | Portland, 97213, United States |
Completed | Richmond, 23249, United States | |
Completed | Birmingham, 35294-3300, United States | |
Completed | BONDY, 93143, France | |
Completed | VANDOEUVRE-LES-NANCY, 54500, France | |
Completed | PARIS, 75020, France | |
Completed | PARIS, 75571, France | |
Completed | MARSEILLE, 13005, France | |
Completed | Seattle, 98109, United States | |
Completed | Ann Arbor, 48109, United States | |
Withdrawn | La Jolla, 92093-0987, United States | |
Completed | Pittsburgh, 15213, United States | |
Completed | Portland, 97239, United States | |
Completed | Boston, 02114, United States | |
Completed | Los Angeles, 90095-7077, United States | |
Completed | Houston, 77030, United States | |
Completed | Columbus, 43210, United States | |
Completed | Burlington, 01805, United States | |
Completed | Cleveland, 44195, United States | |
Completed | New Orleans, 70112, United States | |
Completed | Seattle, 98101, United States | |
Completed | San Francisco, 94115, United States | |
Completed | ANGERS cedex 09, 49933, France | |
Completed | CRETEIL, 94010, France | |
Completed | RENNES, 35000, France | |
Completed | VILLEJUIF, 94800, France | |
Completed | Yokohama-shi, 232-0024, Japan | |
Completed | Shibuya-ku, 150-8935, Japan | |
Completed | Osakasayama-shi, 589-8511, Japan | |
Completed | Kumamoto, 860-8556, Japan | |
Completed | Kyoto, 606-8507, Japan | |
Completed | Itabashi-ku, 173-8610, Japan | |
Completed | Suita, 565-0871, Japan | |
Completed | Bunkyo-ku, 113-8655, Japan | |
Completed | Osaka, 537-8511, Japan | |
Completed | Minato-ku, 105-8470, Japan | |
Withdrawn | Palermo, 90127, Italy | |
Completed | Bologna, 40138, Italy | |
Completed | Atlanta, 30322, United States | |
Completed | Louisville, 40202, United States | |
Completed | Minneapolis, 55407, United States | |
Completed | Baltimore, 21287, United States | |
Completed | Cleveland, 44106, United States | |
Completed | Boston, 02215, United States | |
Completed | BORDEAUX, 33000, France | |
Completed | LILLE, 59037, France | |
Completed | TOULOUSE, 31059, France | |
Completed | LYON, 69004, France | |
Completed | NICE, 06202, France | |
Withdrawn | Kawasaki, 213-8587, Japan | |
Completed | Fukuoka, 812-8582, Japan | |
Completed | Chuo-ku, 104-0045, Japan | |
Completed | Kashiwa-shi, 277-8577, Japan | |
Completed | Milano, 20121, Italy | |
Completed | Cagliari, 09134, Italy | |
Completed | Milano, 20133, Italy | |
Completed | Padova, 35128, Italy | |
Completed | Barcelona, 08036, Spain | |
Completed | Barcelona, 08035, Spain | |
Completed | Córdoba, 14004, Spain | |
Completed | Valladolid, 47012, Spain | |
Completed | Oviedo, 33011, Spain | |
Completed | Sabadell, 08208, Spain | |
Completed | Toronto, M5G 2M9, Canada | |
Completed | Calgary, T2N 4N1, Canada | |
Completed | Ottawa, K1H 8L6, Canada | |
Completed | Edmonton, T6G 1Z2, Canada | |
Completed | Vancouver, V5Z 4E6, Canada | |
Completed | Okayama, 700-8558, Japan | |
Completed | Kanazawa, 920-8641, Japan | |
Completed | Tokushima, 770-8503, Japan | |
Completed | Shinjuku-ku, 162-8666, Japan | |
Completed | Napoli, 80123, Italy | |
Completed | Palermo, 90127, Italy | |
Completed | Benevento, 82100, Italy | |
Completed | Roma, 00168, Italy | |
Withdrawn | Foggia, 71013, Italy | |
Completed | Catania, 95122, Italy | |
Completed | Torino, 10126, Italy | |
Completed | Bari, 70124, Italy | |
Completed | Modena, 41124, Italy | |
Completed | Napoli, 80131, Italy | |
Completed | Cruces/Barakaldo, 48903, Spain | |
Completed | Majadahonda, 28222, Spain | |
Withdrawn | Halifax, B3H 2Y9, Canada | |
Completed | BRUXELLES - BRUSSEL, 1200, Belgium | |
Completed | LEUVEN, 3000, Belgium | |
Completed | México, D.F., 14080, Mexico | |
Completed | Stockholm, 141 86, Sweden | |
Completed | Heidelberg, 3084, Australia | |
Completed | Randwick, 2031, Australia | |
Completed | Melbourne, 3004, Australia | |
Completed | Varna, 2010, Bulgaria | |
Completed | Plovdiv, 4002, Bulgaria | |
Withdrawn | Lisboa, 1069-166, Portugal | |
Withdrawn | Buenos Aires, C1093AAS, Argentina | |
Withdrawn | Guaymallen, M5519GLU, Argentina | |
Completed | Innsbruck, 6020, Austria | |
Withdrawn | A Coruña, 15006, Spain | |
Completed | Madrid, 28040, Spain | |
Completed | Madrid, 28007, Spain | |
Completed | Badajoz, 06080, Spain | |
Withdrawn | Montreal, H3A 1A1, Canada | |
Completed | LIEGE, 4000, Belgium | |
Completed | GENT, 9000, Belgium | |
Completed | Monterrey, 64710, Mexico | |
Completed | México, D.F., 14050, Mexico | |
Completed | Göteborg, 413 45, Sweden | |
Withdrawn | St Leonards, 2065, Australia | |
Completed | Camperdown, 2050, Australia | |
Completed | Brisbane, 4120, Australia | |
Withdrawn | Sofia, 1784, Bulgaria | |
Withdrawn | Sofia, 1606, Bulgaria | |
Completed | Linz, 4020, Austria | |
Completed | Reñaca, Chile | |
Withdrawn | Thessaloniki, 540 07, Greece | |
Completed | Porto Alegre, 90610-000, Brazil | |
Completed | Porto Alegre, 90035-903, Brazil | |
Completed | Sao Paulo, 01246-903, Brazil | |
Completed | Obninsk, 249036, Russia | |
Completed | Moscow, 115478, Russia | |
Completed | Guangzhou, 510060, China | |
Completed | Guangzhou, 510080, China | |
Completed | Chengdu, 610041, China | |
Completed | Nanjing, 210002, China | |
Completed | Shanghai, 200438, China | |
Withdrawn | Shanghai, 200032, China | |
Completed | Coimbra, 3000-075, Portugal | |
Withdrawn | Buenos Aires, C1280AEB, Argentina | |
Completed | Buenos Aires, C1181ACH, Argentina | |
Completed | Pilar, B1629ODT, Argentina | |
Completed | Rosario, S2002KDS, Argentina | |
Withdrawn | Buenos Aires, C1118AAT, Argentina | |
Completed | Wien, 1090, Austria | |
Completed | Santiago de Chile, 833-0024, Chile | |
Completed | Athens / Greece, 115 27, Greece | |
Withdrawn | Larissa, 41100, Greece | |
Completed | Porto Alegre, 90470 340, Brazil | |
Completed | Wuhan, 430022, China | |
Completed | Guangzhou, 510515, China | |
Completed | Chongqing, 400038, China | |
Completed | Xi'an, 710068, China | |
Completed | Wuhan, 430022, China | |
Completed | Changsha, 410013, China | |
Completed | Dalian, 116027, China | |
Completed | Changsha, 410013, China | |
Withdrawn | Hangzhou, 310022, China | |
Completed | Beijng, 100142, China | |
Completed | Changsha, 410008, China | |
Completed | Seoul, 120-752, Korea, Republic Of | |
Completed | Seoul, 110-744, Korea, Republic Of | |
Completed | Goyang-si, 411-706, Korea, Republic Of | |
Completed | São Paulo, 01323-001, Brazil | |
Withdrawn | Voronezh, 394000, Russia | |
Withdrawn | Moscow, 115478, Russia | |
Completed | Moscow, 119991, Russia | |
Completed | St. Petersburg, 197758, Russia | |
Completed | Beijing, 100021, China | |
Completed | Beijing, 100142, China | |
Completed | Beijing, 100071, China | |
Completed | Xi'an, 710061, China | |
Completed | Tianjin, 300060, China | |
Completed | Beijing, 100853, China | |
Completed | Guangzhou, 510080, China | |
Completed | Xi'an, 710038, China | |
Completed | Nanning, 530021, China | |
Completed | Busan, 49241, Korea, Republic Of | |
Completed | Jeollabuk-do, 561-712, Korea, Republic Of | |
Completed | Bern, 3010, Switzerland | |
Completed | Zürich, 8091, Switzerland | |
Completed | Kaohsiung City, 807, Taiwan | |
Withdrawn | Chiclayo, CIX, Peru | |
Withdrawn | Lima, LIMA 11, Peru | |
Withdrawn | Christchurch, 8011, New Zealand | |
Completed | Auckland, 1023, New Zealand | |
Completed | Cluj-Napoca, 400015, Romania | |
Completed | Bucharest, 022326, Romania | |
Completed | Hefei, 230022, China | |
Completed | Shanghai, 200001, China | |
Completed | Seoul, 05505, Korea, Republic Of | |
Completed | Seoul, 135-710, Korea, Republic Of | |
Completed | Goyang-si, 410-769, Korea, Republic Of | |
Completed | Seoul, 135-720, Korea, Republic Of | |
Completed | Daegu, 700721, Korea, Republic Of | |
Completed | Changhua, 500-06, Taiwan | |
Completed | Taipei, 100, Taiwan | |
Completed | Taipei, 112, Taiwan | |
Completed | Kaohsung, 833, Taiwan | |
Withdrawn | San Borja, Peru | |
Completed | Hong Kong, Hong Kong | |
Withdrawn | Hongkong, Hong Kong | |
Completed | Singapore, 169608, Singapore | |
Completed | Singapore, 119228, Singapore | |
Withdrawn | Bucharest, 11172, Romania | |
Withdrawn | Iasi, 700111, Romania | |
Completed | Iasi, 700106, Romania | |
Completed | Chengdu, 610072, China | |
Completed | Taoyuan, 333, Taiwan | |
Completed | 704, Taiwan | |
Completed | Shatin, Hong Kong | |
Completed | Kwun Tong, Hong Kong |
Primary Outcome
- Recurrence Free Survival (RFS) by Independent AssessmentDisease recurrence of HCC (intra or extra hepatic) was defined as the appearance of a new intrahepatic lesions fulfilling the American Association for the Study of Liver Diseases (AASLD) criteria of diagnosis of HCC or a new extra-hepatic lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. In addition to investigator assessment, all images were reviewed by an independent panel of radiologists. The calculation of the RFS was based on the independent evaluation of the scans. RFS was defined as the time from randomization to the first documented disease recurrence by independent radiological assessment or death due to any cause whichever occurred first. For subjects who had not recurred or died at the time of analysis, RFS was censored at their last date of evaluable scan before drop-out for any other reason than recurrence or death.date_rangeTime Frame:From randomization up to 4 years or until disease recurrence whichever came firstenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Time to Recurrence (TTR) by Independent AssessmentTTR was defined as the time from randomization to the first documented disease recurrence by independent radiological assessment. For subjects who had not recurred at the time of analysis, TTR was censored at their last date of evaluable scan before withdrawal for any other reason than recurrence. "NA" in the reported data indicates values could not be estimated due to censored data.date_rangeTime Frame:From randomization up to 4 years or until disease recurrence whichever came firstenhanced_encryptionNoSafety Issue:
- Overall Survival (OS)OS was defined as the time from randomization to date of death due to any cause. OS for subjects alive at the time of analysis was censored at their last date of contact. 'NA' in the reported data indicates values could not be estimated due to censored data.date_rangeTime Frame:From randomization of the first subject until 4 years later.enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find information about studies related to Bayer Healthcare products conducted in EuropeClick here to find results for studies related to Bayer Healthcare products.