Trial Condition(s):
Carcinoma, Hepatocellular
Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM) (STORM)
Bayer Identifier:
12414
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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).
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Investigative Site München, Germany, 81675 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 12200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aachen, Germany, 52074 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Regensburg, Germany, 93042 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göttingen, Germany, 37075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, NW3 2QG | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Birmingham, United Kingdom, B15 2TT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Southampton, United Kingdom, SO16 6YD | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leeds, United Kingdom, LS9 7TF | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newcastle Upon Tyne, United Kingdom, NE7 7DN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New York, United States, 10029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Miami, United States, 33136 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Indianapolis, United States, 46202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 20246 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Halle/Saale, Germany, 06120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Düsseldorf, Germany, 40225 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Essen, Germany, 45147 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Magdeburg, Germany, 39120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Köln, Germany, 50937 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Homburg/Saar, Germany, 66421 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, SE5 9RS | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Manchester, United Kingdom, M20 4BX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Washington, United States, 20007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Minneapolis, United States, 55455 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Phoenix, United States, 85054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Providence Portland Medical Center Portland, United States, 97213 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Richmond, United States, 23249 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Birmingham, United States, 35294-3300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BONDY, France, 93143 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site VANDOEUVRE-LES-NANCY, France, 54500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75571 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MARSEILLE, France, 13005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seattle, United States, 98109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ann Arbor, United States, 48109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pittsburgh, United States, 15213 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Portland, United States, 97239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boston, United States, 02114 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90095-7077 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Burlington, United States, 01805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cleveland, United States, 44195 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Seattle, United States, 98101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Francisco, United States, 94115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ANGERS cedex 09, France, 49933 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CRETEIL, France, 94010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site RENNES, France, 35000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site VILLEJUIF, France, 94800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yokohama-shi, Japan, 232-0024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shibuya-ku, Japan, 150-8935 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osakasayama-shi, Japan, 589-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kumamoto, Japan, 860-8556 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kyoto, Japan, 606-8507 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Itabashi-ku, Japan, 173-8610 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Suita, Japan, 565-0871 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bunkyo-ku, Japan, 113-8655 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 537-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Minato-ku, Japan, 105-8470 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site BORDEAUX, France, 33000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LILLE, France, 59037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site TOULOUSE, France, 31059 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LYON, France, 69004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NICE, France, 06202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukuoka, Japan, 812-8582 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chuo-ku, Japan, 104-0045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kashiwa-shi, Japan, 277-8577 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20121 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cagliari, Italy, 09134 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20133 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Córdoba, Spain, 14004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valladolid, Spain, 47012 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oviedo, Spain, 33011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sabadell, Spain, 08208 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M5G 2M9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Calgary, Canada, T2N 4N1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ottawa, Canada, K1H 8L6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Edmonton, Canada, T6G 1Z2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vancouver, Canada, V5Z 4E6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Okayama, Japan, 700-8558 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kanazawa, Japan, 920-8641 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tokushima, Japan, 770-8503 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shinjuku-ku, Japan, 162-8666 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Napoli, Italy, 80123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Palermo, Italy, 90127 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Benevento, Italy, 82100 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Catania, Italy, 95122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Torino, Italy, 10126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bari, Italy, 70124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Modena, Italy, 41124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cruces/Barakaldo, Spain, 48903 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Majadahonda, Spain, 28222 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site México, D.F., Mexico, 14080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 141 86 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Australia, 3084 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Randwick, Australia, 2031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Melbourne, Australia, 3004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Varna, Bulgaria, 2010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Plovdiv, Bulgaria, 4002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Badajoz, Spain, 06080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Monterrey, Mexico, 64710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site México, D.F., Mexico, 14050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göteborg, Sweden, 413 45 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Camperdown, Australia, 2050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brisbane, Australia, 4120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linz, Austria, 4020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Reñaca, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Porto Alegre, Brazil, 90610-000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Porto Alegre, Brazil, 90035-903 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sao Paulo, Brazil, 01246-903 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Obninsk, Russia, 249036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 115478 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guangzhou, China, 510060 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guangzhou, China, 510080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chengdu, China, 610041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nanjing, China, 210002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200438 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Coimbra, Portugal, 3000-075 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Pilar, Argentina, B1629ODT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rosario, Argentina, S2002KDS | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santiago de Chile, Chile, 833-0024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Athens / Greece, Greece, 115 27 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Wuhan, China, 430022 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Beijng, China, 100142 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Changsha, China, 410008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 120-752 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Goyang-si, South Korea, 411-706 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Moscow, Russia, 119991 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 197758 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100021 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Tianjin, China, 300060 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Nanning, China, 530021 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Jeollabuk-do, South Korea, 561-712 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Taipei, Taiwan, China, 100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 112 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Iasi, Romania, 700106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chengdu, China, 610072 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taoyuan, Taiwan, China, 333 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Taiwan, China, 704 | Contact Us: E-mail: [email protected] Phone: Not Available |
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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
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.Timeframe: From randomization up to 4 years or until disease recurrence whichever came first
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.Timeframe: From randomization up to 4 years or until disease recurrence whichever came first
- 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.Timeframe: From randomization of the first subject until 4 years later.
Additional Information
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