Back to resultsSorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM) (STORM)
Primary Purpose
Carcinoma, Hepatocellular
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nexavar (Sorafenib, BAY43-9006)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Hepatocellular carcinoma, Sorafenib, Adjuvant, Surgical resection, Ablation, Nexavar, Adjuvant therapy, Liver cancer, HCC, STORM
Eligibility 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.
- 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
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 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
Sites / Locations
- Providence Portland Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sorafenib (Nexavar, BAY43-9006)
Placebo
Arm Description
Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
Participants received 2 tablets of placebo orally twice daily (BID)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00692770
Brief Title
Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)
Acronym
STORM
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 15, 2008 (Actual)
Primary Completion Date
November 29, 2013 (Actual)
Study Completion Date
November 28, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
Hepatocellular carcinoma, Sorafenib, Adjuvant, Surgical resection, Ablation, Nexavar, Adjuvant therapy, Liver cancer, HCC, STORM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sorafenib (Nexavar, BAY43-9006)
Arm Type
Experimental
Arm Description
Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received 2 tablets of placebo orally twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
Nexavar (Sorafenib, BAY43-9006)
Intervention Description
Sorafenib 400 mg twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 2 tablets twice daily (BID)
Primary Outcome Measure Information:
Title
Recurrence Free Survival (RFS) by Independent Assessment
Description
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.
Time Frame
From randomization up to 4 years or until disease recurrence whichever came first
Secondary Outcome Measure Information:
Title
Time to Recurrence (TTR) by Independent Assessment
Description
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.
Time Frame
From randomization up to 4 years or until disease recurrence whichever came first
Title
Overall Survival (OS)
Description
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.
Time Frame
From randomization of the first subject until 4 years later.
Other Pre-specified Outcome Measures:
Title
Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Index Score
Description
The EQ-5D is a generic quality of life preference based on a validated instrument used in cancer and in general population, with 2 parts: Index and Visual Analogue Scale. The EQ-5D Index is a descriptive system of the following health dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Subjects were asked to choose any one of the 3 response levels for each dimension: no problems, some problems, and severe problems. The 5 health dimensions were summarized into a single score, the EQ-5D Index score which ranged from -0.59 to 1 with higher scores representing better health states (0=death, 1= perfect health, and -0.59=a health state worse than death). A change of at least 0.10 to 0.12 points was considered a minimally important difference using Eastern Cooperative Oncology Group Performance Status as the anchor. The results on the Analysis of covariance of timeadjusted Area under curve for the EQ-5D index score were reported.
Time Frame
Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit
Title
Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Visual Analogue Scale (VAS) Score
Description
The EQ-5D is a generic quality of life preference based on a validated instrument used in cancer and in general population, with 2 parts: Index and Visual Analogue Scale. The EQ-5D VAS is a measure that represents health status as a single value. It is a 20-centimetre vertical graduated visual analogue scale with scores that ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). The respondent rated his/her current health state by drawing a line from the box marked 'your own health state today' to the appropriate point on the EQ-5D VAS. A 3-digit number (including leading zeros) was read off the scale from the point where the respondent's line crossed the scale, which was the EQ-5D VAS score. A change of at least 7 points on the VAS was considered as minimally important. The results on the ANCOVA analysis of time-adjusted AUC for the EQ-5D VAS score were reported.
Time Frame
Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit
Title
Patient Reported Outcomes: Functional Assessment of Cancer Therapy (FACT)- Hepatobiliary Subscale (HEP) Score
Description
The FACT-HEP is a 45 item, self-administered, multi-dimensional, psychometrically sound questionnaire used extensively in oncology clinical trials. FACT-HEP consisted of five subscales: Physical Well-Being (PWB), Social Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and Hepatobiliary Cancer Subscale (HCS). The PWB, FWB, SWB and EWB were summed to form the FACTGeneral (FACT-G) total score. The FACT-G and HCS scores were summed to form the FACT-HEP total score. FACT-HEP scores ranged from 0 to 180 and the higher scores represented a better quality of life. Subjects responded to each item on a 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). The minimally important difference (MID) for the FACT-Hep total score was in the range of 8 to 9. The results on the ANCOVA analysis of time-adjusted AUC for the FACT-HEP score were reported.
Time Frame
Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit
Title
Patient Reported Outcomes: Functional Assessment of Cancer Therapy (FACT)- General (G) Total Score
Description
The PWB, FWB, SWB and EWB were summed to form the FACT-G total score. Subjects responded to each item on a 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). FACT-G scores ranged from 0 to 108 and the higher scores represented a better quality of life. The MID for the FACT-G total score was in the range of 6 to 7. The results on the ANCOVA analysis of time-adjusted AUC for the FACT-G score were reported.
Time Frame
Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit
Title
The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - ANG-2
Description
Biomarker was analyzed at baseline [i.e., before treatment] as a dichotomized variable based on median biomarker levels, and dichotomized into "high" and "low" groups using an optimal max chi cut-off approach - not per intervention. As such, results were analyzed according to this stratification. Max-chi square methodology was used to search for the optimal cut point for dichotomization of each plasma biomarker and Kaplan-Meier curves were generated using the optimal cut point for each possible association examined. These biomarker analyses were retrospective and exploratory and of signal generating nature only.
Time Frame
At Baseline
Title
The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - AFP
Description
Biomarker was analyzed at baseline [i.e., before treatment] as a dichotomized variable based on median biomarker levels, and dichotomized into "high" and "low" groups using an optimal max chi cut-off approach - not per intervention. As such, results were analyzed according to this stratification. Max-chi square methodology was used to search for the optimal cut point for dichotomization of each plasma biomarker and Kaplan-Meier curves were generated using the optimal cut point for each possible association examined. These biomarker analyses were retrospective and exploratory and of signal generating nature only.
Time Frame
At Baseline
Title
The Correlation Between Plasma Biomarker Levels at Baseline With RFS to Determine Prognostic Value of Biomarkers - MET
Description
Biomarker was analyzed at baseline [i.e., before treatment] as a dichotomized variable based on median biomarker levels, and dichotomized into "high" and "low" groups using an optimal max chi cut-off approach - not per intervention. As such, results were analyzed according to this stratification. Max-chi square methodology was used to search for the optimal cut point for dichotomization of each plasma biomarker and Kaplan-Meier curves were generated using the optimal cut point for each possible association examined. These biomarker analyses were retrospective and exploratory and of signal generating nature only.
Time Frame
At Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7077
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
B1629ODT
Country
Argentina
City
Buenos Aires
State/Province
Ciudad Auton. De Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2002KDS
Country
Argentina
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Linz
ZIP/Postal Code
4020
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Bruxelles - Brussel
ZIP/Postal Code
1200
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Liege
ZIP/Postal Code
4000
Country
Belgium
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90470 340
Country
Brazil
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01323-001
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
01246-903
Country
Brazil
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
City
Varna
ZIP/Postal Code
2010
Country
Bulgaria
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
City
Santiago de Chile
State/Province
Santiago
ZIP/Postal Code
833-0024
Country
Chile
City
Reñaca
State/Province
Valparaíso
Country
Chile
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710038
Country
China
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710068
Country
China
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
City
Beijing
ZIP/Postal Code
100021
Country
China
City
Beijing
ZIP/Postal Code
100071
Country
China
City
Beijing
ZIP/Postal Code
100142
Country
China
City
Beijing
ZIP/Postal Code
100853
Country
China
City
Beijng
ZIP/Postal Code
100142
Country
China
City
Chongqing
ZIP/Postal Code
400038
Country
China
City
Dalian
ZIP/Postal Code
116027
Country
China
City
Hefei
ZIP/Postal Code
230022
Country
China
City
Shanghai
ZIP/Postal Code
200001
Country
China
City
Shanghai
ZIP/Postal Code
200438
Country
China
City
Tianjin
ZIP/Postal Code
300060
Country
China
City
ANGERS cedex 09
ZIP/Postal Code
49933
Country
France
City
Bondy
ZIP/Postal Code
93143
Country
France
City
Bordeaux
ZIP/Postal Code
33000
Country
France
City
Creteil
ZIP/Postal Code
94010
Country
France
City
Lille
ZIP/Postal Code
59037
Country
France
City
Lyon
ZIP/Postal Code
69004
Country
France
City
Marseille
ZIP/Postal Code
13005
Country
France
City
Nice
ZIP/Postal Code
06202
Country
France
City
Paris
ZIP/Postal Code
75020
Country
France
City
Paris
ZIP/Postal Code
75571
Country
France
City
Rennes
ZIP/Postal Code
35000
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54500
Country
France
City
Villejuif
ZIP/Postal Code
94800
Country
France
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93042
Country
Germany
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
City
Homburg/Saar
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
City
Halle/Saale
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
City
Berlin
ZIP/Postal Code
12200
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Athens / Greece
ZIP/Postal Code
115 27
Country
Greece
City
Hong Kong
Country
Hong Kong
City
Kwun Tong
Country
Hong Kong
City
Shatin
Country
Hong Kong
City
Benevento
State/Province
Campania
ZIP/Postal Code
82100
Country
Italy
City
Napoli
State/Province
Campania
ZIP/Postal Code
80123
Country
Italy
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41124
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20121
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
City
Cagliari
State/Province
Sardegna
ZIP/Postal Code
09134
Country
Italy
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95122
Country
Italy
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90127
Country
Italy
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
150-8935
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
City
Osaka
ZIP/Postal Code
537-8511
Country
Japan
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
City
Goyang-si
State/Province
Gyeonggido
ZIP/Postal Code
410-769
Country
Korea, Republic of
City
Goyang-si
State/Province
Gyeonggido
ZIP/Postal Code
411-706
Country
Korea, Republic of
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
135-720
Country
Korea, Republic of
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
City
Daegu
ZIP/Postal Code
700721
Country
Korea, Republic of
City
Jeollabuk-do
ZIP/Postal Code
561-712
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
City
México, D.F.
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64710
Country
Mexico
City
México, D.F.
ZIP/Postal Code
14050
Country
Mexico
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
City
Bucharest
ZIP/Postal Code
022326
Country
Romania
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
City
Iasi
ZIP/Postal Code
700106
Country
Romania
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
City
Cruces/Barakaldo
State/Province
Bilbao
ZIP/Postal Code
48903
Country
Spain
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
City
Badajoz
ZIP/Postal Code
06080
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
City
Changhua
ZIP/Postal Code
500-06
Country
Taiwan
City
Kaohsiung City
ZIP/Postal Code
807
Country
Taiwan
City
Kaohsung
ZIP/Postal Code
833
Country
Taiwan
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TT
Country
United Kingdom
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26361969
Citation
Bruix J, Takayama T, Mazzaferro V, Chau GY, Yang J, Kudo M, Cai J, Poon RT, Han KH, Tak WY, Lee HC, Song T, Roayaie S, Bolondi L, Lee KS, Makuuchi M, Souza F, Berre MA, Meinhardt G, Llovet JM; STORM investigators. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2015 Oct;16(13):1344-54. doi: 10.1016/S1470-2045(15)00198-9. Epub 2015 Sep 8.
Results Reference
result
PubMed Identifier
30108162
Citation
Pinyol R, Montal R, Bassaganyas L, Sia D, Takayama T, Chau GY, Mazzaferro V, Roayaie S, Lee HC, Kokudo N, Zhang Z, Torrecilla S, Moeini A, Rodriguez-Carunchio L, Gane E, Verslype C, Croitoru AE, Cillo U, de la Mata M, Lupo L, Strasser S, Park JW, Camps J, Sole M, Thung SN, Villanueva A, Pena C, Meinhardt G, Bruix J, Llovet JM. Molecular predictors of prevention of recurrence in HCC with sorafenib as adjuvant treatment and prognostic factors in the phase 3 STORM trial. Gut. 2019 Jun;68(6):1065-1075. doi: 10.1136/gutjnl-2018-316408. Epub 2018 Aug 14.
Results Reference
derived
PubMed Identifier
27887632
Citation
Bouattour M, Soubrane O, de Gramont A, Faivre S. Adjuvant therapies in advanced hepatocellular carcinoma: moving forward from the STORM. Trials. 2016 Nov 25;17(1):563. doi: 10.1186/s13063-016-1675-8.
Results Reference
derived
PubMed Identifier
22212936
Citation
Kudo M. Adjuvant therapy after curative treatment for hepatocellular carcinoma. Oncology. 2011;81 Suppl 1:50-5. doi: 10.1159/000333259. Epub 2011 Dec 22.
Results Reference
derived
PubMed Identifier
19806596
Citation
Printz C. Clinical trials of note. Sorafenib as adjuvant treatment in the prevention of disease recurrence in patients with hepatocellular carcinoma (HCC) (STORM). Cancer. 2009 Oct 15;115(20):4646. doi: 10.1002/cncr.24673. No abstract available.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Learn more about this trial
Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)
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