UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005335 |
|---|---|
| Receipt number | R000006344 |
| Scientific Title | A phase I study of sorafenib/UFT chemotherapy in advanced hepatocellular carcinoma |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2012/04/05 17:36:19 |
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Basic information
Public title
A phase I study of sorafenib/UFT chemotherapy in advanced hepatocellular carcinoma
Acronym
A phase I study of sorafenib/UFT chemotherapy in advanced hepatocellular carcinoma
Scientific Title
A phase I study of sorafenib/UFT chemotherapy in advanced hepatocellular carcinoma
Scientific Title:Acronym
A phase I study of sorafenib/UFT chemotherapy in advanced hepatocellular carcinoma
Region
| Japan |
Condition
Condition
advanced hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the maximum tolerated dose (MTD) and the recommended dose (RD) of sorafenib and UFT in advanced hepatocellular carcinoma (HCC).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Maximum tolerated dose and recommended dose of sorafenib and UFT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Level 1:
Sorafenib 400mg/day + UFT 300 mg/day
Level 2:
Sorafenib 800 mg/day + UFT 300 mg/day
Level 3:
Sorafenib800 mg/day + UFT 400 mg/day
Orally intake both sorafenib and UFT for 28 days as one cycle, continue until 3 cycles.
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Histology/cytology-or clinically (by imaging or tumor marker) proven hepatocellular carcinoma
2)no indication for locoregional therapy, hepatectomy, radiofrequency ablation therapy, chemoemblization or ethnol injection therapy
3) Patients who have target lesions that can be measured with imaging CT or imaging MRI.
4) No carry-over effect or adverse drug reaction of prior treatments. Make following intervals from previous treatments; 2 weeks from a surgery and percutaneous local therapy, 4 weeks from transarterial chemoembolization, transcatheter arterial infusion and radiations.
5) Child-Pugh A
6)ECOG performance status of 0-1
7) The function of the major organ is kept as satisfied by the following requirement (within 14 days before study entry),
Neutrophil >= 1,500/microL
Platelets >= 50,000/microL
Hemoglobin >= 10g/dL
Total bilirubin < 2.0mg/dL
AST or ALT <= 5 *Upper limit of Normal(ULN)
Cr <= 1.5 *ULN
8) Age >= 20 years at informed consent.
9) Patients are considered to keeping procedure of this study such as visit, compliance, having laboratory tests.
10)Acquisition of written informed consent
Key exclusion criteria
1) Treatment with sorafenib or other molecular target drugs in past.
2) Any systemic chemotherapy in past.
3) Patients with ascites possessed clinical meaning. (Requiring drainage)
4) After liver transplantation
5) Esophageal varices with bleeding risk
6) Within 12 months before study entry, following events were happened; acute myocardial infarction, unstable angina, heart failure, cerebrovascular diseases.
7) Hepatic Encephalopathy. (Including as a previous disease)
8) Brain tumors.
9) Hemodialysis.
10) Gastrointestinal bleeding was happened within 1 month before study entry.
11) Active second primary malignancies.
12) Treating with CYP3A4 inducing agents.
(rifampicin, etc.)
13) Patients with following complications; Arrhythmias coming under Grade2 or more of NCI CTCAE v4.0, uncontrolled hypertension
14) Contraindication of UFT and sorafenib
15) Patient with taking herbal medicine approved as a treatment of cancer. (shosaikoto, etc.)
16) Patients with infection of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related diseases.
17) Any patients are pregnant/ nursing
18)Those judged to be not suitable by the attending physician
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Maehara |
Organization
Kyushu University
Division name
Department of Surgery and Science, Graduate School of Medical Sciences
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka
TEL
092-642-5466
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Shirabe |
Organization
Kyushu University
Division name
Department of Surgery and Science, Graduate School of Medical Sciences
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka
TEL
092-642-5466
Homepage URL
kshirabe@surg2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu Univrsity Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
九州大学病院(福岡県)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 29 | Day |
Last modified on
| 2012 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006344
