UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012936 |
|---|---|
| Receipt number | R000015104 |
| Scientific Title | Preventive effect and safety of pregabalin on FOLFOX-related peripheral neurotoxicity for patients with advanced and recurrent colorectal cancer |
| Date of disclosure of the study information | 2014/01/23 |
| Last modified on | 2019/01/29 09:24:39 |
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Basic information
Public title
Preventive effect and safety of pregabalin on FOLFOX-related peripheral neurotoxicity for patients with advanced and recurrent colorectal cancer
Acronym
Perpetual study estimated-by united sections in Gifu for colorectal cancer (PerSeUS CRC-01)
Scientific Title
Preventive effect and safety of pregabalin on FOLFOX-related peripheral neurotoxicity for patients with advanced and recurrent colorectal cancer
Scientific Title:Acronym
Perpetual study estimated-by united sections in Gifu for colorectal cancer (PerSeUS CRC-01)
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 efficacy and safety of pregabalin on FOLFOX-related peripheral neurotoxicity for patients with advanced and recurrent 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 cumulative dose 500mg/m2 of oxaliplatin (Grade2 and more)
Key secondary outcomes
1)Cumurative dose to occurrence of neurotoxicity
2)Time to occurrence of neurotoxicity
3)The number of FOLFOX treatment courses
4)Relative dose intensity of oxaliplatin
5)FACT/GOG-Ntx and verval rating scale
6)Adverse events
7)Response rate
8)Progression free survival
9)Time to treatment failure
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
In case of FOLFOX related-peripheral neurotoxicity (Grade1), pregabalin is administered.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed colorectal cancer.
2)No prior chemotherapy. However, patients with recurrence more than 6 months after completion of adjuvant chemotherapy with other than oxaliplatin were also eligible.
3)ECOG PS of 0 or 1
4)Age ranging between 20 and 75 years old
5)A life expectancy of more than 12 weeks
6)Satisfactory oral feeding
7)Adequate function of vital organs, including bone marrow, heart, lungs, liver and kidneys, laboratory data within 28 days before registration
Neutrophil >=1,500/mm3
Platelet >=100.000/mm3
Hemoglobin >=9.0g/dL
AST and ALT <=100IU/L (<=200IU/L if the patient has liver metastasis)
Total bililbin <=2.0mg/dL
Serum creatinine <=1.5mg/dL
Creatinine clearance >=60mL/min
8)Written informed consent
Key exclusion criteria
1)Serious drug allergy
2)Neuropathy or sensory dysfunction
3)History of oxaliplatin treatment
4)Preventive administration for oxaliplatin-related neuropathy
5)Pain in the arm or foot
6) Current analgesic treatment
7)Active double cancer within the past 5 years
8)A systemic inflammatory condition or serious infection
9)Pregnant or lactating women
10)Serious psychological disease
11)Steroid treatment
12)Blood transfusion or hemopoietic factors (e.g. G-CSF) within 7 days
13)Pleural effusion, ascites, or pericardial effusion
14)Clinically significant heart disease
15)Clinically significant pulmonary disease
16)Gastrointestinal bleeding that requires medication or transfusion
17)Watery diarrhea
18)Ileus or bowel obstruction
19)Uncontrolled diabetes mellitus with or without diabetic neuropathy
20) Investigator's judgement
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Yoshida |
Organization
Gifu University graduate school of medicine
Division name
Department of surgical oncology
Zip code
Address
1-1 Yanagido, Gifu city, Gifu, Japan
TEL
058-230-6000
kyoshida@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhisa Matsuhashi |
Organization
Gifu University graduate school of medicine
Division name
Department of surgical oncology
Zip code
Address
1-1 Yanagido, Gifu city, Gifu, Japan
TEL
058-246-1111
Homepage URL
nobuhisa517@hotmail.com
Sponsor or person
Institute
PerSeUS: Perpetual Study estimated-by United Sections in Gifu
Institute
Department
Personal name
Funding Source
Organization
Office of PerSeUS
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 12 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 23 | Day |
Last modified on
| 2019 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015104
