UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of second-line chemotherapy using modified FOLFOX6 in patients with advanced/ recurrent colorectal cancer (OGSG 0505)
Acronym	OGSG 0505
Scientific Title	Phase II study of second-line chemotherapy using modified FOLFOX6 in patients with advanced/ recurrent colorectal cancer (OGSG 0505)
Scientific Title:Acronym	OGSG 0505
Region	Japan

Condition
Condition	Patients with unresectable or metastatic colon cancer registant to fluorouracil treatment
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	A mFOLFOX treatment is evaluated in terms of response rate and adverse events for patients with unresectable or metastatic colon cancer who underwent fluorouracil treatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response Rate(RECIST), Duration of response
Key secondary outcomes	Overall Survival, Feasibility Adverse Events

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	DAY 1 day 2 day 14 L-OHP 2HR l-LV 200mg/m2 5-FU 2,400mg/m2 civ 2HR 46HR ....... | 5-FU 400mg/m2 iv Rapid
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 proven histologically 2) unresectable or metastatic colon cancer 3) with prior chemotherapy of fluoropyrimidine O the last prior therapy before more than 4 weeks of registration O without L-OHP therapy O For patients with postoperative adjuvant chemotherapy, progression is observed on x-ray examination or tumor marker examination within 26 weeks of adjuvant chemotheray. 4) with measurable metastatic lesions 5) age: =>20 and 75=> 6) Performance Status: 0-1 (ECOG criteria) 7) more than 12 weeks of expected survival period 8) sufficient function of important organs O WBC: >= 4,000 and =< 12,000/mm3 O Platelet: >= 100,000/mm3 O sGOT,sGPT: 2.5 times of normal range in each institute O sT.bil.: <= 1.5 mg/dl O sCreatinin: <= upper limit of each institute O ECG: normal range 9) written informed consent
Key exclusion criteria	"1) Cavity fluid which needs drainage 2) with active double cancer except ca. in situ 3) with peripheral nerve disorder 4) with infectious disease which needs treatment 5) under watery diarrhea 6) with mental disorder which disturbs registration to this study 7) patients who receive steroids treatment 8) Cardiac failure, liver dysfunction, or renal dysfunction which disturb Registration to this study 9) pregnant women or women who like to be pregnant 10) history of severe allergy against drug 11) doctor's dicision not to be registered to this study"
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mishima Hideyuki
Organization	National Hospital Orgamnzation Osaka Medical Center
Division name	Dpt.Surgery
Zip code
Address	2-1-14.Houenzaka, chuo-ku, Osaka, 540-0006
TEL	06-6942-1331
Email

Public contact
Name of contact person	1st name Middle name Last name Furukawa Hiroshi
Organization	Sakai City Hospital
Division name	Director
Zip code
Address	1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064
TEL
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 10 Month 11 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	Completed
Date of protocol fixation	2005 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date	2005 Year 06 Month 01 Day
Last follow-up date	2007 Year 04 Month 01 Day
Date of closure to data entry	2007 Year 04 Month 01 Day
Date trial data considered complete	2008 Year 08 Month 01 Day
Date analysis concluded	2008 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date	2007 Year 10 Month 04 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=R000001011