UMIN-CTR Clinical Trial

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 (OGSG 0406)
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 (OGSG 0406)
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	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=R000000918