UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009464 |
|---|---|
| Receipt number | R000010922 |
| Scientific Title | Preventive effect of pregabalin on oxaliplatin-related neurotoxicity for patients with advanced/recurrent colorectal cancer: a prospective phase 2 study |
| Date of disclosure of the study information | 2012/12/04 |
| Last modified on | 2013/03/21 04:55:51 |
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Basic information
Public title
Preventive effect of pregabalin on oxaliplatin-related neurotoxicity for patients with advanced/recurrent colorectal cancer: a prospective phase 2 study
Acronym
Preventive effect of pregabalin on oxaliplatin-related neurotoxicity for patients with advanced/recurrent colorectal cancer: a prospective phase 2 study(POPLAR Study)
Scientific Title
Preventive effect of pregabalin on oxaliplatin-related neurotoxicity for patients with advanced/recurrent colorectal cancer: a prospective phase 2 study
Scientific Title:Acronym
Preventive effect of pregabalin on oxaliplatin-related neurotoxicity for patients with advanced/recurrent colorectal cancer: a prospective phase 2 study(POPLAR Study)
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect and safety of pregabalin on neurotoxicity of FOLFOX or XELOX for patients 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
Neurotoxicity frequency of accumulation dose 500mg/m2 of L-OHP (Grade2 or more)
Key secondary outcomes
1)Median dose of L-OHP
2)nerve disorder at the end of oxaliplatin-based regimen (each course Grade)
3)the psychometric properities of the FACT/GOG-Ntx
4)PFS and TTF
5)response rate
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
Pregabalin is administered during FOLFOX or XELOX therapy.
Initial dose:75mg twice daily(150mg/day),increased to 300 - 600mg/day if there was persistent paresthesia or functional impariment(Grade2 or more).
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)Histologically confirmed adenocarcinoma of the colon and rectum
2)No prior chemotherapy,immunotherapy and radiotherapy
3)Age 20<=years
4)Life expectancy at least 12 weeks
5)more than 2 weeks after surgical operation(more than 4 weeks with bevacizumab)
6)Performance Status(ECOG) 0-1
7)without any disorder in the important organs and with good results of the Examinations seven days before the registeration
8)patients who can take food orally
9)written informed consent
Key exclusion criteria
1)Patients who had received blood transfusion, blood products , or hematopoietic growth factors such as granulocyte-colony stimulating factor(G-CSF) within 7 days prior to registration
2)with brain metastasis
3)with much cavity fluid to be removed
4)with active double cancer
5)allergy against medicines
6)uncontrolled Hypertension
7)Prior or current thrapy for neuropathy or sensory dysfunction.
8)uncontrolled DM
9)active infection desease
10)watery diarrhea
11)disorderon EKG
12)severe respiratory disease(interstital pneumonitis,plumonary fibrosis,Severe pulmonary emphysema)
13)psychiatric disorder
14)fresh bleeding on the digestive tract
15)pregnant and/or nursing women
16)Doctor's stop not to be registered
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satohsi Hirai |
Organization
Toyama Prefectural Central Hospital
Division name
Department of outpatient chemotherapy and Gastroenterological medicine
Zip code
Address
2-2-78 Nishinagae,Toyama-shi,Toyama-ken,930-8550
TEL
076-424-1531
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satohsi Hirai |
Organization
Toyama Prefectural Central Hospital
Division name
Department of outpatient chemotherapy and Gastroenterological medicine
Zip code
Address
2-2-78 Nishinagae,Toyama-shi,Toyama-ken,930-8550
TEL
076-424-1531
Homepage URL
sh915@bc5.so-net.ne.jp
Sponsor or person
Institute
Toyama Prefectural Central 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
富山県立中央病院 外来化学療法科/内科(消化器)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 04 | 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
| 2012 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 04 | 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
| 2012 | Year | 12 | Month | 03 | Day |
Last modified on
| 2013 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010922
