UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009126 |
|---|---|
| Receipt number | R000010698 |
| Scientific Title | Evaluation of efficacy of dose escalation strategy for treatment with sorafenib for hepatocellular carcinoma. |
| Date of disclosure of the study information | 2012/10/16 |
| Last modified on | 2017/04/19 13:15:31 |
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Basic information
Public title
Evaluation of efficacy of dose escalation strategy for treatment with sorafenib for hepatocellular carcinoma.
Acronym
Evaluation of efficacy of dose escalation strategy for treatment with sorafenib for hepatocellular carcinoma.
Scientific Title
Evaluation of efficacy of dose escalation strategy for treatment with sorafenib for hepatocellular carcinoma.
Scientific Title:Acronym
Evaluation of efficacy of dose escalation strategy for treatment with sorafenib for hepatocellular carcinoma.
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We examine the usefulness of the dose escalation strategy as a means to prevent discontinuation due to adverse events in the sorafenib treatment for patients with HCC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compared with the previously reported the TTS and the OS.
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
Sorafenib Tosilate (Nexavar)
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. The patient's age is between 20 and 89 years old.
2. Unresectable HCC progression.
3. Child-Pugh class A or B.
4. PS 2 or less.
5. With or without treatment history of HCC.
6. Informed consent.
Key exclusion criteria
1. Brain metastases.
2. Bleeding tendency.
3. Advanced ascites.
4. Hepatic encephalopathy (II or more).
5. Jaundice (serum bilirubin value of 3.0 mg/dL or more).
6. Serum AST or ALT value of more than 200 IU/L.
7. Hemoglobin blood value of less than 8.0 g/dL.
8. Neutrophil count of less than 1000 /microL.
9. Platelet count of less than 50000 /microL.
10. Difficult to control hypertension.
11. During dialysis.
12. Patients who are pregnant, suspected to be pregnant or breastfeeding.
13. Patient with drug allergy.
14. Patient uses other anticancer drugs.
15. Patients who are considered not to be eligible by the investigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Toshikuni |
Organization
Kanazawa Medical University
Division name
Department of Gastroenterology
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
076-286-2211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Toshikuni |
Organization
Kanazawa Medical University
Division name
Department of Gastroenterology
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
076-286-2211
Homepage URL
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | 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
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
| 2012 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
| 2016 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 16 | Day |
Last modified on
| 2017 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010698
