UMIN-CTR Clinical Trial

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 &#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	2021 Year 11 Month 15 Day

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