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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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)
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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.
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Secondary ID [1]
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2008-001087-36
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Secondary ID [2]
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12414
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Universal Trial Number (UTN)
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Trial acronym
STORM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Hepatocellular
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0
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Condition category
Condition code
Cancer
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0
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Non melanoma skin cancer
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Cancer
0
0
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0
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Kidney
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Cancer
0
0
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0
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Liver
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Intervention/exposure
Study type
Interventional
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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)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Recurrence Free Survival (RFS) by Independent Assessment
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Assessment method [1]
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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.
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Timepoint [1]
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From randomization up to 4 years or until disease recurrence whichever came first
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Secondary outcome [1]
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Time to Recurrence (TTR) by Independent Assessment
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Assessment method [1]
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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.
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Timepoint [1]
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From randomization up to 4 years or until disease recurrence whichever came first
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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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.
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Timepoint [2]
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From randomization of the first subject until 4 years later.
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/08/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/11/2014
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Sample size
Target
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Accrual to date
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Final
1114
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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- Camperdown
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Recruitment hospital [2]
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- Randwick
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- Brisbane
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- Heidelberg
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- Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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2031 - Randwick
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4120 - Brisbane
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment outside Australia
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Sweden
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State/province [125]
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0
Stockholm
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Country [126]
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0
Switzerland
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State/province [126]
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Bern
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Country [127]
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Switzerland
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State/province [127]
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Zürich
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Country [128]
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Taiwan
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State/province [128]
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Changhua
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Country [129]
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Taiwan
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State/province [129]
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Kaohsiung City
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Country [130]
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Taiwan
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State/province [130]
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Kaohsung
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Country [131]
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Taiwan
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State/province [131]
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Tainan
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Country [132]
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Taiwan
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State/province [132]
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Taipei
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Country [133]
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Taiwan
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State/province [133]
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Taoyuan
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Country [134]
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United Kingdom
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State/province [134]
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Hampshire
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Country [135]
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United Kingdom
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State/province [135]
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West Midlands
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Country [136]
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United Kingdom
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State/province [136]
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West Yorkshire
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Country [137]
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United Kingdom
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State/province [137]
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London
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Country [138]
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United Kingdom
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State/province [138]
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Manchester
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Country [139]
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United Kingdom
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State/province [139]
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Newcastle Upon Tyne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bayer
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Address
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Country
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00692770
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bayer Study Director
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Address
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Bayer
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00692770
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