UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of FOLFOX4 in patients with advanced/recurrent colorectal cancer previously treated with 5FU (OGSG 0503)
Acronym	OGSG0503
Scientific Title	Phase II study of FOLFOX4 in patients with advanced/recurrent colorectal cancer previously treated with 5FU (OGSG 0503)
Scientific Title:Acronym	OGSG0503
Region	Japan

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

Objectives
Narrative objectives1	A phase II study is designed to evaluate the response and feasibility of FOLFOX4 in patients with advanced/recurrent colorectal cancer previously treated with 5FU
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response Rate
Key secondary outcomes	Incidence of Adverse Events,Feasibility,Survival Time, Relative Dose Intensity

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	FOLFOX 4 Treatment Day 1: 1. L-OHP 85mg/m2 is mixed with 250 cc of 5% glucose infusion.(A) 2. l-LV 100 mg/m2 is mixed with 250 cc of 5% glucose infusion.(B) 3. A and B are drip-infused by 2 hours using Y connection. 4. 5-FU 400mg/m2 is infused by 15 minutes, intravenously 5. 5-FU 600 mg/m2 is infused by 22 hours. Day 2: 1. l-LV 100mg/m2 is infused by 2 hours. 2. 5-FU 400 mg/m2 is infused by 15 minutes. 3. 5-FU 600 mg/m2 is infused by 22 hours
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	Eligibility criteria (1) colorectal cancer, histologically (2) advanced or recurrent colorectal cancer (3) colorectal cancers previously treated with 5FU which satisfy the following factors * more than 4 weeks after the end of prior chemotherapy ( more than two weeks if patients have progressive lesions) &#61548;without previous L-OHP therapy &#61548;When patients have been undergone chemotherapy, some signs of progression of tumor &#61548;were found in CT or tumor markers within 26 weeks. (4) with measurable lesions (5) age: older than 20 years and younger than 75years (6) Performance Status: 0-2 in ECOG criteria (7) Longer than 12 weeks of expected survival (8) sufficient function in the important organs WBC 4,000<= and =< 12,000 mm3/dl Platelet 100,000/mm3 <= Total bilirubin within 1.5 times of normal range of each institute AST, ALT within 2.5 times of normal range in each institute Serum creatinin within normal range of each institute ECG normal range 10) written informed consents
Key exclusion criteria	Excluding Criteria 1. cavity fluid which should be taken out 2. with double cancer and/or multiple cancer which excludes carcinoma in situ 3. with peripheral nerve disorder 4. with infectious disease 5. under the condition of diarrhea (watery diarrhea) 6. with psychological disorder which disturb the entry to the study 7. under continuous steroids therapy 8. with other severe diseases(pulmonary fibrosis, cardiac failure, liver dysfunction, renal dysfunction, intestinal paralysis/obstruction or uncontrolled DM) 9. pregnant and/or nursing women 10. with allergic history against medicines 11. doctors' stop not to register to the study
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mishima Hideyuki
Organization	National Hospital Organization Osaka National Hospital
Division name	Dpt.Surgery
Zip code
Address	2-1-14,Houenzaka,Chuou-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	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 06 Month 15 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 04 Month 21 Day
Date of IRB
Anticipated trial start date	2005 Year 04 Month 01 Day
Last follow-up date	2008 Year 01 Month 01 Day
Date of closure to data entry	2008 Year 10 Month 01 Day
Date trial data considered complete	2008 Year 10 Month 01 Day
Date analysis concluded	2008 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date	2007 Year 06 Month 07 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=R000000882