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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000734
Receipt No. R000000882
Scientific Title Phase II study of FOLFOX4 in patients with advanced/recurrent colorectal cancer previously treated with 5FU
Date of disclosure of the study information 2007/06/15
Last modified on 2009/04/02

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Basic information
Public title Phase II study of FOLFOX4 in patients with advanced/recurrent colorectal
cancer previously treated with 5FU
Acronym OGSG0503
Scientific Title Phase II study of FOLFOX4 in patients with advanced/recurrent colorectal
cancer previously treated with 5FU
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
2009 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000882

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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