UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010438 |
|---|---|
| Receipt number | R000012204 |
| Scientific Title | To protect peripheral oxaliplatin-related neuralgia by pregabalin in Kansai area |
| Date of disclosure of the study information | 2013/04/08 |
| Last modified on | 2013/04/07 22:33:17 |
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Basic information
Public title
To protect peripheral oxaliplatin-related neuralgia by pregabalin in Kansai area
Acronym
To protect peripheral oxaliplatin-related neuralgia by pregabalin in Kansai area : HARUKA study
Scientific Title
To protect peripheral oxaliplatin-related neuralgia by pregabalin in Kansai area
Scientific Title:Acronym
To protect peripheral oxaliplatin-related neuralgia by pregabalin in Kansai area : HARUKA study
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect and safety of pregabalin on neurotoxicity of FOLFOX for patients with metastatic colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Time to neuropathy(grade<2:CTCAEv4.0)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pregabalin is administered during FOLFOX therapy.
Initial dose:75mg twice daily(150mg/day),possible to increase the dose 300mg/day(maximam dose).
Interventions/Control_2
only mFOLFOX6 administration
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Written informed consent
2)Patients who is judged by investigator to be able to receive the protocol therapy
3)Patients with histologically proven colorectal cancer and lower edge of tumor located upper than Douglas pouch
4)p-Stage2,3a,3b
5)R0 (Curability A)
6)Age; 20<=, <=80
7)ECOG performance status 0-1
8)within 8 weeks from operation
9) Patiens have enough organ function based on blood test
1.WBC>=3,000-<=12,000/mm3, 2.Neurtophils>=1,500/mm3
3. Platelets>=100,000/mm3
4. Hemoglobin>=9.0g/dl
5. Total bilirubin<=2.0mg/dl
6.AST<=100U/L
7.ALT<=100U/L
8. Creatinine>=30ml/minute
Key exclusion criteria
1)transfusion, G-CSF etc. within 7days
2)severe allergic reaction
3)peripheral neuropthy
4)Simultaneous or metachronous double cancers
5)Active infectious disease
6)Severe mental disease
7)Grade2+, diarrhea
8)systemic administration of corticosteroids
9)Pregnant or lactating women or women of childbearing potential
10)Severe comorbidity (interstitial peumonitis, lung fibrosis, paralytic ileus, mechanical ileus, uncontrollable diabetes, liver cirosis, chronic hepatitis, career with hepatitis B/C, renal failure, heart failure, uncontrollable hypertension, unstable angina etc)
11)AMI within 6 months
12)History of transplantation
13)Preoperative therapy for CRC
14)History of colostomy
15)Unhealing of post-operative complication
16)Gashajinkigan, or drug for neuropathy
17)Any other cases who are regarded as inadequate for study enrollment by the investigator
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Maeda |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
1-4-3, Asahi-machi, abeno-ku, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Nagahara |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
1-4-3, Asahi-machi, abeno-ku, Osaka
TEL
Homepage URL
Sponsor or person
Institute
Osaka City University Graduate School of Medicine Department of Surgical Oncology
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate School of Medicine Department of Surgical Oncology
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
| 2013 | Year | 04 | Month | 08 | 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 | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 15 | 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
| 2013 | Year | 04 | Month | 07 | Day |
Last modified on
| 2013 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012204
