check_circleStudy Completed

Carcinoma, Hepatocellular

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

Both

Age

18 - N/A
  • - 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.
    - At least 3 weeks (21 days) but no more than 7 weeks (49 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
  • - 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 as defined by the signing of informed consent..
    - Uncontrolled ascites (defined as not easily controlled with diuretic treatment)
    - Encephalopathy
    - History of GI bleeding within 30 days of randomization.
    - 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 for treatment of HCC (including sorafenib or any other molecular therapy) is excluded.
    - Major surgery within 4 weeks of start of study as defined by the signing of informed consent, except for surgical resection or local ablation of HCC.
    - Investigational drug therapy outside of this trial during or within 4 weeks of study entry, as defined by the signing of informed consent.
    - Liver transplantation, this includes patients on a transplant list with the intention to transplant

Trial summary

Enrollment Goal
1114
Trial Dates
August 2008 - November 2014
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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 CenterPortland, 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 Assessment
    Disease 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 first
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Time to Recurrence (TTR) by Independent Assessment
    TTR 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 first
    enhanced_encryption
    Safety Issue:
    No
  • 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_encryption
    Safety Issue:
    No

Trial design

A Phase III randomized, double-blind, placebo-controlled study of sorafenib as adjuvant treatment for hepatocellular carcinoma after surgical resection or local ablation.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2