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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003252
Receipt No. R000003933
Scientific Title Phase II trial of DIF drug as adjuvant therapy after curative resection of colon cancer - Investigation of risk facter for colon cancer-
Date of disclosure of the study information 2010/03/01
Last modified on 2010/02/24

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Basic information
Public title Phase II trial of DIF drug as adjuvant therapy after curative resection of colon cancer - Investigation of risk facter for colon cancer-
Acronym Phase II trial of DIF drug as adjuvant therapy after curative resection of colon cancer
Scientific Title Phase II trial of DIF drug as adjuvant therapy after curative resection of colon cancer - Investigation of risk facter for colon cancer-
Scientific Title:Acronym Phase II trial of DIF drug as adjuvant therapy after curative resection of colon cancer
Region
Japan

Condition
Condition Colon cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To explore effectiveness and saftety of UFT/LV or TS-1 followed by UFT for prevention of stage II/III colon cancer reccurence.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Relapse free survival
Key secondary outcomes Overall survival,Compliance, Relation of risk facter, Measurement of anticancer drug-sensitive facter

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are 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 UFT/LV
UFT 300mg/m2/day
LV 750mg/day
for 28 days followed by a 7-day rest period (one cycle=5 weeks)X5 cycle

or
TS-1
80mg/m2/day
for 28 days followed by a 14-day rest period (one cycle = 6 weeks) X 4 cycle

UFT
400mg/body/day
450mg/body/day
for 1.5 years treatind UFT/LV or TS-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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) histopathologically proven colon cancer
2) pathological stage 2 (high risk),3
3) resection of histological curability A was performed
4) ECOG PS 0-2
5) 20-80 years old
6) no prior chemotherapy and radiotherapy
7) adequate organ function
8) Written informed consent
Key exclusion criteria 1) Contraindications of using UFT, LV, TS-1
2) active double cancer except ca. in situ
3) Severe postoperative complication
4) Serious coexisting illness
a)uncontrolled diabetes mellitus
b)uncontrolled hypertension
c)history of myocardial infarction, unstable angina within 6 months prior to the registration severe
d)liver cirrhosis
e)pulmonary dysfunction
5) pregnant or nursing patient or with intent to bear baby
6) mental disorder or psychiatric symptom
7) HIV infection
8) Disqualified by attending doctor
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimikazu Hamano
Organization Yamaguchi University
Division name Department of Surgery and Clinical Science
Zip code
Address 1-1-1, Minamikogushi, Ube, Yamaguchi, Japan
TEL 0836-22-2261
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tadahiko Enoki
Organization Yamaguchi University
Division name Department of Surgery and Clinical Science
Zip code
Address 1-1-1, Minamikogushi, Ube, Yamaguchi, Japan
TEL 0836-22-2261
Homepage URL http://ds.cc.yamaguchi-u.ac.jp/~surg-1/
Email surg-1@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University
Department of Srgery and Clinical Science
Institute
Department

Funding Source
Organization none
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 小野田市民病院(山口県)
済生会下関総合病院(山口県)
済生会山口総合病院(山口県)
周東総合病院(山口県)
光市立大和総合病院(山口県)
徳山総合病院(山口県)
長門総合病院(山口県)
萩市民病院(山口県)
光市立光総合病院(山口県)
三田尻病院(山口県)
山口県立総合医療センター(山口県)
山口労災病院(山口県)
愛媛労災病院(愛媛県)
下関医師会病院(山口県)


Other administrative information
Date of disclosure of the study information
2010 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 Enrolling by invitation
Date of protocol fixation
2008 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2015 Year 06 Month 01 Day
Date of closure to data entry
2015 Year 08 Month 01 Day
Date trial data considered complete
2015 Year 09 Month 01 Day
Date analysis concluded
2015 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 02 Month 24 Day
Last modified on
2010 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003933

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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