UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000718 |
|---|---|
| Receipt number | R000000857 |
| Scientific Title | Phase II study of using Carbamazepine for neurosensory toxicity related FOLFOX regimens in patients with advanced/recurrent colorectal cancer (OGSG 0603) |
| Date of disclosure of the study information | 2007/05/25 |
| Last modified on | 2021/11/15 23:00:34 |
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Basic information
Public title
Phase II study of using Carbamazepine for neurosensory toxicity related FOLFOX regimens in patients with advanced/recurrent colorectal cancer (OGSG 0603)
Acronym
OGSG 0603
Scientific Title
Phase II study of using Carbamazepine for neurosensory toxicity related FOLFOX regimens in patients with advanced/recurrent colorectal cancer (OGSG 0603)
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 – 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
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
Sponsor or person
Institute
OGSG
Institute
Department
Personal name
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
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
| 2021 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000857
