UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010621 |
|---|---|
| Receipt number | R000012413 |
| Scientific Title | Phase II study of efficacy and safety of duloxetine for chlonic oxaliplatin-induced peripheral neuropathy in metastatic colorectal cancer |
| Date of disclosure of the study information | 2013/07/02 |
| Last modified on | 2013/07/02 16:36:15 |
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Basic information
Public title
Phase II study of efficacy and safety of duloxetine for chlonic oxaliplatin-induced peripheral neuropathy in metastatic colorectal cancer
Acronym
Phase II study of efficacy and safety of duloxetine for chlonic oxaliplatin-induced peripheral neuropathy
Scientific Title
Phase II study of efficacy and safety of duloxetine for chlonic oxaliplatin-induced peripheral neuropathy in metastatic colorectal cancer
Scientific Title:Acronym
Phase II study of efficacy and safety of duloxetine for chlonic oxaliplatin-induced peripheral neuropathy
Region
| Japan |
Condition
Condition
advanced colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy and safety of duloxetine in patients of peripheral neuropathy with metastatic colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
prolongation of period of oxaliplatin treatment
Key secondary outcomes
safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
duloxetine
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age>=20years
2) Patients with histopathologically proven unresectable advanced colorectal adenocarcinoma (including cecal cancer)
3)Gr1 peripheral neuropathy
4) ECOG performance status 0-2.
including cetuximab, or panitumumab
5)Adequate hematologic, renal, hepatic and metabolic function :
6) Written informed consent obtained from the patient
Key exclusion criteria
1)having other active malignancies
2) severe complications (uncontrolled diabetes mellitus, interstitial lung disease, pulmonary fibrosis, heart failure ,renal failure, hepatic failure, etc.)
3) having active infections
4) history of severe drug hypersensitivity
5) uncontrollable serious mental problem
7) pregnant or female intend to be pregnant, and male intend to make pregnant.
8) peripheral neuropathy>=Gr2
9)Others
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Taira |
Organization
Osaka City General Hospital
Division name
Department of Clinical Oncology
Zip code
Address
2-13-22 Miyakojimahonndori Miyakojima-ku Osaka city
TEL
0669291221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Taira |
Organization
Osaka City General Hospital
Division name
Department of Clinical Oncology
Zip code
Address
TEL
Homepage URL
koichit@iris.eonet.ne.jp
Sponsor or person
Institute
Osaka City General Hospital Department of Clinical Oncology
Institute
Department
Personal name
Funding Source
Organization
Osaka City General Hospital Department of Clinical Oncology
Organization
Division
Category of Funding Organization
Local Government
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
| 2013 | Year | 07 | Month | 02 | 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
| 2013 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 30 | Day |
Last modified on
| 2013 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012413
