UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Sequential hepatic arterial infusion chemotherapy with cisplatin followed by sorafenib versus sorafenib alone in advanced hepatocellular carcinoma
Title of the study (Brief title)	SCOOP-2 trial
Region	Japan

Condition
Condition	Hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of prior transcatheter arterial infusion chemotherapy using cisplatin powder in patients with advanced HCC who are candidates for sorafenib treatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	1-year survival
Key secondary outcomes	overall survival, 2-year survival, time to progression, response rate, safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Sorafenib
Interventions/Control_2	Sequential hepatic arterial infusion chemotherapy with cisplatin followed by sorafenib
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) 20 Years and older. 2) Life expectancy of at least 12 weeks at the pre-treatment evaluation. 3) Advanced hepatocellular carcinoma with histological evidence on a biopsy specimen, or typical findings by dynamic CT or MRI. 4) Not suitable for resection or local ablation therapy or transcatheter arterial chemoembolization. 5) At least 4 weeks since last therapy for HCC. 6) Patients with no sorafenib and a fine-powder formulation of cisplatin therapy. 7) Intrahepatic tumor which affects patient'prognosis. 8) Extrahepatic tumor apread which not affects patient's prognosis. 9)Adequate indication for fine-puwder formulation of cisplatin therapy. 10) ECOG Performance status of 0 or 1. 11) Cirrhotic status of Child-Pugh score 5-7. 12) Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements: Granulocyte >= 1000/mm3 Platelet count >= 50,000 /mm3 Hemoglobin >= 8.5 g/dl Total serum bilirubin <= 3 mg/dl AST and ALT <= 5 times upper limit of normal Serum creatinine <= 1.5 mg/dl Amylase <= 2 times upper limit of normal 13) Written Informed Consent must be obtained.
Key exclusion criteria	1) Esophageal and/or gastric varices which has high risk of bleeding and clinically significant gastro- intestinal bleeding. 2) Clinically uncontrolled ascites or pleural effusion. 3) Existing of hepatic encephalopathy 4) Serious hypertension. 5) Preexisting of history with severe coronary or cerebral artery diseases. 6) Renal failure. 7) Patients who are pregnant, suspected to be pregnant, or wish to become pregnant. 8) Risk of allergic reactions to the study drugs. 9) Active duplicative cancer 10) Previous malignancy 11) Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
Target sample size	90

Research contact person
Name of lead principal investigator	Katsuaki Tanaka
Organization	Yokohama City University Medical Center
Division name	Gastroenterlogical Center
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	k_tanaka@yokohama-cu.ac.jp

Public contact
Name of contact person	Masaaki Kondo
Organization	Yokohama City University Medical Center
Division name	Gastroenterlogical Center
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	mkondou@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	The Waksman Foundation of Japan
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	横浜市立大学附属市民総合医療センター（神奈川県） 神奈川県立がんセンター（神奈川県） 聖マリアンナ医科大学病院（神奈川県） 川崎市立多摩病院（神奈川県） 聖マリアンナ医科大学横浜市西部病院（神奈川県） 北里大学東病院（神奈川県） 広島大学病院（広島県） 伊勢崎市民病院（群馬県）

Other administrative information
Date of disclosure of the study information	2011 Year 08 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 07 Month 22 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date	2016 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 08 Month 11 Day
Last modified on	2017 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007270