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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00692770




Registration number
NCT00692770
Ethics application status
Date submitted
5/06/2008
Date registered
6/06/2008
Date last updated
8/08/2018

Titles & IDs
Public title
Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)
Scientific title
A Phase III Randomized, Double-blind, Placebo-controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma After Surgical Resection or Local Ablation.
Secondary ID [1] 0 0
2008-001087-36
Secondary ID [2] 0 0
12414
Universal Trial Number (UTN)
Trial acronym
STORM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Hepatocellular 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nexavar (Sorafenib, BAY43-9006)
Treatment: Drugs - Placebo

Experimental: Sorafenib (Nexavar, BAY43-9006) - Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)

Placebo Comparator: Placebo - Participants received 2 tablets of placebo orally twice daily (BID)


Treatment: Drugs: Nexavar (Sorafenib, BAY43-9006)
Sorafenib 400 mg twice daily (BID)

Treatment: Drugs: Placebo
Placebo 2 tablets twice daily (BID)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
From randomization up to 4 years or until disease recurrence whichever came first
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
From randomization up to 4 years or until disease recurrence whichever came first
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
From randomization of the first subject until 4 years later.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
- Camperdown
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- Randwick
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- Brisbane
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- Heidelberg
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- Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4120 - Brisbane
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
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United States of America
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Alabama
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Argentina
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Ciudad Auton. De Buenos Aires
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Argentina
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Santa Fe
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Wien
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Belgium
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Bruxelles - Brussel
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Gent
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Leuven
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Liege
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ANGERS cedex 09
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Rennes
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Vandoeuvre-les-nancy
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Villejuif
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Bayern
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Niedersachsen
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Saarland
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Germany
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Sachsen-Anhalt
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Berlin
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Hamburg
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Kwun Tong
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Shatin
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Kyoto
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Okayama
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Tokushima
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Korea, Republic of
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Gyeonggido
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Coimbra
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Romania
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Bucharest
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Cluj-Napoca
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Romania
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Iasi
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Russian Federation
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Moscow
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Russian Federation
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Obninsk
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St. Petersburg
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Singapore
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Singapore
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Spain
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Asturias
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Barcelona
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Bilbao
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Catalunya
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Córdoba
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Spain
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Valladolid
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Sweden
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Göteborg
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Sweden
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Stockholm
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Switzerland
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Bern
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Switzerland
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Zürich
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Taiwan
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Changhua
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Taiwan
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Kaohsiung City
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Kaohsung
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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United Kingdom
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Hampshire
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West Midlands
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West Yorkshire
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London
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Manchester
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United Kingdom
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Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT00692770
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications