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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000727
Receipt No. R000000872
Scientific Title Phase II study of a combination of modified CPT-11 and 5-FU/l-LV (mJIFL) in patients with meatastatic colorectal cancer
Date of disclosure of the study information 2007/06/08
Last modified on 2009/12/04

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Basic information
Public title Phase II study of a combination of modified CPT-11 and 5-FU/l-LV (mJIFL) in patients with meatastatic colorectal cancer
Acronym OGSG 0601
Scientific Title Phase II study of a combination of modified CPT-11 and 5-FU/l-LV (mJIFL) in patients with meatastatic colorectal cancer
Scientific Title:Acronym OGSG 0601
Region
Japan

Condition
Condition Meatastatic 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 of modified CPT-11 and 5-FU/l-LV (mJIFL) for the patients with meatastatic colorectal cancer is carried out to evaluate the response and to know the feasibility.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response Rate
Key secondary outcomes Time To Progression(TTP), Time To Treatment Failure (TTF), 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 On Day 1, 8, 15,
CPT-11 100 mg/m2
l-LV 250 mg/m2 administered simultaneously
5-FU 500 mg/m2 administered subsequently
** It takes 28 days for the one course.
** More than two courses are required.
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) advanced or recurrent colon cancer with metastatic lesions
2) colon cancer proven by cytologic and/or histologic examination
3) with measurable lesions which are larger than 2 cm by CT sliced 10 mm
or larger than 1cm by CT sliced 5 mm.
4) without any prior chemotherapy, or with prior CPT-11 therapy after 4
Weeks of last administration
5) without radiation therapy
6) age: 20 <= and => 75 years old
7) performance status: 0-1(ECOG classification)
8) Expected survival period is longer than 13 weeks.
9) with sufficient function on the important organs
WBC 3,000<= and =< 12,000 mm3/dl
Neutrocyte 1,500mm3 <=
Hemoglobin 8.0 g.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 1. with interstitial pneumonitis or pulmonary fibrosis
2. cavity fluid which should be taken out
3. with double cancer and/or multiple cancer which excludes carcinoma in situ
4. with infectious disease, intestinal paralysis, or intestinal obstraction
5. under the condition of diarrhea (watery diarrhea)
6. under insulin therapy or uncontrolled DM
7. with ulcer on digestive organs
8. with ischemic cardiac disease
9. with psychological disorder which disturb the entry to the study
10. under HBs-Antigen(+), HCV antibody(+), or HIV antibody(+)
11. under continuous steroids therapy
12. with other severe diseases(cardiac failure, liver dysfunction, or renal
dysfunction)
13. brain metastasis with some symptoms
14. pregnant and/or nursing women
15. with allergic history against medicines
16. doctors' stop not to register to the study
Target sample size 54

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 08 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 Terminated
Date of protocol fixation
2006 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2006 Year 07 Month 01 Day
Last follow-up date
2007 Year 03 Month 01 Day
Date of closure to data entry
2007 Year 03 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 05 Month 31 Day
Last modified on
2009 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000872

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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