UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006147 |
|---|---|
| Receipt number | R000007270 |
| Scientific Title | Sequential hepatic arterial infusion chemotherapy with cisplatin followed by sorafenib versus sorafenib alone in advanced hepatocellular carcinoma |
| Date of disclosure of the study information | 2011/08/11 |
| Last modified on | 2017/02/17 11:46:49 |
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Basic information
Public title
Sequential hepatic arterial infusion chemotherapy with cisplatin followed by sorafenib versus sorafenib alone in advanced hepatocellular carcinoma
Acronym
SCOOP-2 trial
Scientific Title
Sequential hepatic arterial infusion chemotherapy with cisplatin followed by sorafenib versus sorafenib alone in advanced hepatocellular carcinoma
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Katsuaki Tanaka |
Organization
Yokohama City University Medical Center
Division name
Gastroenterlogical Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
k_tanaka@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Kondo |
Organization
Yokohama City University Medical Center
Division name
Gastroenterlogical Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
mkondou@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 22 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007270
