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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000766
Receipt No. R000000918
Scientific Title A phase I study to evaluate the effect and recommended dose of 5-FU(rapid infusion and drip infusion)/l-LV therapy for advanced and/or recurrent colon cancer
Date of disclosure of the study information 2007/07/13
Last modified on 2007/08/02

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Basic information
Public title A phase I study to evaluate the effect and recommended dose of 5-FU(rapid infusion and drip infusion)/l-LV therapy for advanced and/or recurrent colon cancer
Acronym OGSG 0406
Scientific Title A phase I study to evaluate the effect and recommended dose of 5-FU(rapid infusion and drip infusion)/l-LV therapy for advanced and/or recurrent colon cancer
Scientific Title:Acronym OGSG 0406
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 I clincal study is carried out to evaluate the dose limited toxicity, maximum tolerant dose, or recommended dose on 5-FU(rapid and continuous infusion) plus l-LV for advanced or recurrent colon cancer.
Basic objectives2 Others
Basic objectives -Others DLT,MTD,RD,Feasibility
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes DLT, MTD, RD
Key secondary outcomes Feasibility

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 Agents dose rout day
l-LV 200mg/m2 div(2 hours) day 1
5-FU 400mg/m2 iv(5 min) day 1
5-FU Xmg/m2 civ(46 hours) day 1
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. histologically proven colon cancer
2. Age: 20-75 yo
3. Performance status: 0-1 (ECOG criteria)
4. without any prior chemotherapy or with longer than 4 weeks of no-therapy period after prior chemotherapy
5. with sufficient bone marrow, renal or hepatic function
Hemoglobin 8.0 g/dl <=
WBC: 4,000 /mm3 <= and =< 12,000/mm3
Neutrocyte: 2,000/mm3=<
Platelet: 100,000/mm3 =<
Total bilirubin: within normal range of each hospital
GOT, GPT: within 2 times of normal limit of each hospital
Creatinin: within normal range
CRP: 2mg/dl =>
BUN: <= 25mg/dl
alb: >=3g/dl
cardiac function: tolereble to the regimen of this study
6. without hepatitis virus infection (HBs Ag, HCV Ab)
7. expected survival period longer than 3 months
8. written informed consent
Key exclusion criteria 1.with severe bone marrow suppression
2.with a severe infection
3.with severe cardiac disease
4.with some other severe diseases
5.under a poor general condition
6.under diarrhea which continues more than three days
7.with double cancers which were treated within recent 5 years except carcinoma in situ.
8.with familial polyposis or hereditary disease
9.under pregnancy or nursing
10.with a history of allergic response to Levoholinate or fluorouracil
11.re-registration to this study
12.doctors' decision not to register
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fukunaga Mutsumi
Organization Sakai City Hospital
Division name Dpt.Surgery
Zip code
Address 1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064
TEL 072-221-1700
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 07 Month 13 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
2004 Year 09 Month 09 Day
Date of IRB
Anticipated trial start date
2004 Year 10 Month 01 Day
Last follow-up date
2005 Year 10 Month 01 Day
Date of closure to data entry
2005 Year 11 Month 01 Day
Date trial data considered complete
2006 Year 03 Month 01 Day
Date analysis concluded
2007 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 07 Month 06 Day
Last modified on
2007 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000918

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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