UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003252 |
|---|---|
| Receipt number | 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 19:15:18 |
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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
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/
surg-1@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Department of Srgery and Clinical Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003933
