UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014566 |
|---|---|
| Receipt number | R000016948 |
| Scientific Title | A randomized, open, Phase II comparison of the safety and efficacy of a reduced and re-escalated dose of sorafenib versus a reduced and maintained dose of sorafenib in patients with advanced hepatocellular carcinoma. |
| Date of disclosure of the study information | 2014/07/16 |
| Last modified on | 2023/07/22 10:27:52 |
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Basic information
Public title
A randomized, open, Phase II comparison of the safety and efficacy of a reduced and re-escalated dose of sorafenib versus a reduced and maintained dose of sorafenib in patients with advanced hepatocellular carcinoma.
Acronym
A randomized, open, Phase II comparison of the safety and efficacy of a reduced and re-escalated dose of sorafenib versus a reduced and maintained dose of sorafenib in patients with advanced hepatocellular carcinoma.
Scientific Title
A randomized, open, Phase II comparison of the safety and efficacy of a reduced and re-escalated dose of sorafenib versus a reduced and maintained dose of sorafenib in patients with advanced hepatocellular carcinoma.
Scientific Title:Acronym
A randomized, open, Phase II comparison of the safety and efficacy of a reduced and re-escalated dose of sorafenib versus a reduced and maintained dose of sorafenib in patients with advanced hepatocellular carcinoma.
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of a reduced and re-escalated dose of sorafenib versus a reduced and maintained dose of sorafenib in patients with advanced hepatocellular carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to progression after randomization
Key secondary outcomes
Overall Survival
Overall survival after randomization; OS after randomization
Time to progression
Drug concentration of sorafenib
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dose re-escalation of sorafenib from reduce dose
Interventions/Control_2
Continued sorafenib with reduce dose
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 or more
2) Presence of histologically confirmed or clinically diagnosed hepatocellular carcinoma
3) Absence of benefit from a treatment of established efficacy, such as resection, local ablation, and transarterial chemoembolization
4) Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1
5) Presence of Child-Pugh score 7 or less
Key exclusion criteria
1) History of a primary tumor diagnosed in the past 3 years
2) Presence of active bacterial infections, HIV/AIDS, or other diseases that would preclude study participation
3) Presence of uncontrolled or significant cardiovascular disease
4) Regular phenytoin or warfarin use
5) Presence of mental incapacity or psychiatric illness.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Osamu |
Organization
Chiba university hospital
Division name
Department of Gastroenterology
Zip code
2608670
Address
1-8-1 Inohana Chuo-ku Chiba
TEL
043-222-7171
yokosukao@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Sadahisa |
| Middle name | |
| Last name | Ogasawara |
Organization
Chiba university hospital
Division name
Department of Gastroenterology
Zip code
2608670
Address
1-8-1 Inohana Chuo-ku Chiba
TEL
043-222-7171
Homepage URL
sadahisa@me.com
Sponsor or person
Institute
Chiba university hospital
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin, Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital Clinical Research Center
Address
1-8-1 Inohana Chuo-ku Chiba
Tel
043-222-7171
chibacrc@mac.com
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 16 | 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
114
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
| 2014 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 10 | 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
| 2014 | Year | 07 | Month | 15 | Day |
Last modified on
| 2023 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016948
