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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000613
Receipt No. R000000741
Scientific Title Phase II study of a combination of CPT-11, 5FU/l-LV and UFT/LV in patients with advanced/recurrent colorectal cancer
Date of disclosure of the study information 2007/03/01
Last modified on 2009/12/04

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Basic information
Public title Phase II study of a combination of CPT-11, 5FU/l-LV and UFT/LV in patients with advanced/recurrent colorectal cancer
Acronym OGSG0605
Scientific Title Phase II study of a combination of CPT-11, 5FU/l-LV and UFT/LV in patients with advanced/recurrent colorectal cancer
Scientific Title:Acronym OGSG0605
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 Phase II study of a combination of CPT-11,5-FU/l-LV and UFT/LV in patients with advanced/recurrent colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes adverse events, overall survival,progression-free survival,time to treatment failure.

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 It takes 2 weeks for one course and that is to be repeated.
Dose schedule for one course
CPT-11 150mg/ m2/day Day 1
5-FU 500 mg/m2/day Day 1
l-LV 15 mg/m2/day Day 1
UFT 300 mg/m2/day Day 1-8 morning
LV 75 mg/day Day 1-8 morning
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) diagnosed as colon cancer
pathologically
2)with measurable lesions
3)without prior chemotherapy
4)without prior radiation therapy
5)20 years old <= => 75 years old
6)Performance status: 0 &#8211; 1 (ECOG)
7)Expected survival more than 12 weeks
8)Within labo. data level written,
subsequently
WBC >= 4,000/mm3 and <= 12,000/mm3
Neutrocyte >= 2,000/mm3
Platelet >= 100,000/mm3
sGOT, sGPT <upper limit of each
institute x 2.5
sBil <= 2.0mg/dl
creatinin <= upper limit of each
institute
Normal ECG
9)Informed Consents with written form
10) Patients who can take orally
Key exclusion criteria 1)interstitial pneumonitis or pulmonary
fibrosis
2)with cavity fluid to be treated
3)with present active double cancer or
D.B. diagnosed less than 5 years
before, excluding cured cancer in situ
or skin cancer
4)ileus
5)watery diarrhea
6)D.M. which needs insulin or
uncontrolled D.M.
7)With other diseases which influence
to the study (heart diseases, liver
dysfunction, renal failure)
8)brain metastasis with some symptoms
9)pregnant women or suspected women
10)receiving atazanavir sulfate
11)Receiving steroids treatment
12)With experience of drug anaphylaxis
shock
13)Doctor stop due to miscellaneous
factors
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TAMURA TAKAO
Organization KOBE UNIVEISITY
Division name Dpt.Digestive Diseases
Zip code
Address 7-5-1,Ksunokicho,Chuoku,Kobe 650-0017
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization OGSG
Division name Office
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Osaka Gastrointestinal Cancer Chemotherapy Study Group (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 03 Month 01 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
2007 Year 01 Month 23 Day
Date of IRB
Anticipated trial start date
2007 Year 02 Month 01 Day
Last follow-up date
2009 Year 02 Month 01 Day
Date of closure to data entry
2009 Year 02 Month 01 Day
Date trial data considered complete
2009 Year 02 Month 01 Day
Date analysis concluded
2009 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 02 Month 19 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=R000000741

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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