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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000718
Receipt No. R000000857
Scientific Title Phase II study of using Carbamazepin for neurosensory toxicity related FOLFOX regimens in patients with advanced/recurrent colorectal cancer
Date of disclosure of the study information 2007/05/25
Last modified on 2008/08/21

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Basic information
Public title Phase II study of using Carbamazepin for neurosensory toxicity related FOLFOX regimens in patients with advanced/recurrent colorectal cancer
Acronym OGSG 0603
Scientific Title Phase II study of using Carbamazepin for neurosensory toxicity related FOLFOX regimens in patients with advanced/recurrent colorectal cancer
Scientific Title:Acronym OGSG 0603
Region
Japan

Condition
Condition advanced/recurrent colon cancer or rectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To test the feasibility of Carmazepin therapy and to evaluate whether Carmazepin has the protective and/or prophylactic effects against peripheral nerve syndrome due to FOLFOX therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To test the feasibility of Carmazepin therapy and to evaluate whether Carmazepin has the protective and/or prophylactic effects against peripheral nerve syndrome due to FOLFOX therapy
Key secondary outcomes Median dose of L-OHP, nerve disorder at the end of FOLFOX, Course, PFS and TTF, Response Rate

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 Carbamazepin is administered during FOLFOX therapy.
Carbamazepin tablet 100mg, 200mg or granule including Car. 500mg in 1000mg
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) colon cancer or rectal cancer, histologically
(2) eligible in the both patients with prior therapy and without any prior therapy
(3) eligible in the both patients with and without measurable lesions
(4) age between >= 20 years old and <= 75 years old
(5) with the expected survival period more than 12 weeks
(6) more than 4 weeks after surgical operation
(7) Performance Status (ECOG) 0-1
(8) without any disorder in the important organs and with good results of the
Examinations seven days before the registeration
WBC: 3,000 &#8211; 12,000 /mm3
Neutrocyte: more than 1,500/mm3
Platelet: more than 100,000/mm3
s Total Bil: within 1.5 times of normal range
sAST, sALT, sALP: within 2.5 times of normal range
s Creatinin: within the normal range
(9) written informed consent
(10) patients who can take food orally
Key exclusion criteria (1) Patients who received transfusion, blood components or GCSF within seven days Before 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) receiving digitalis
(8) uncontrolled DM
(9) active infectious disease
(10) watery diarrhea
(11) disorder on EKG
(12) severe respiratory diseases (interstitial pneumonitis, pulmonary fibrosis, Severe pulmonary emphysema)
(13) psychiatric disorder
(14) fresh bleeding on the digestive tract
(15) sensory nerve disorder
(16) pregnant and/or nursing women
(17) driving a complicated mechanism or vehicle
(18) Doctors' stop not to be registered
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Katou
Organization Minoo municipal hospital
Division name Dpt.Surgery
Zip code
Address 562-8562 5-7-1 Kayano,Minoo-shi,Osaka 562-8562
TEL 072-728-2001
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Sakai Cdty Hospital
Division name Director
Zip code
Address 1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064
TEL 072-221-1700
Homepage URL
Email

Sponsor
Institute OGSG
Institute
Department

Funding Source
Organization NPO Osaka Chinical Study Supporting Organization
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
Email

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
2007 Year 05 Month 25 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
2006 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2006 Year 08 Month 01 Day
Last follow-up date
2007 Year 07 Month 01 Day
Date of closure to data entry
2007 Year 07 Month 01 Day
Date trial data considered complete
2007 Year 12 Month 01 Day
Date analysis concluded
2008 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 05 Month 17 Day
Last modified on
2008 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000857

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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