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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000346
Receipt No. R000000433
Scientific Title A randomized clinical trial of adjuvant chemotherapy with TS-1 versus UFT following curative operation for Stage III colorectal cancer
Date of disclosure of the study information 2006/04/01
Last modified on 2016/05/24

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Basic information
Public title A randomized clinical trial of adjuvant chemotherapy with TS-1 versus UFT following curative operation for Stage III colorectal cancer
Acronym A randomized study of TS-1 versus UFT as adjuvant therapy in patients with Stage III colorectal cancer
Scientific Title A randomized clinical trial of adjuvant chemotherapy with TS-1 versus UFT following curative operation for Stage III colorectal cancer
Scientific Title:Acronym A randomized study of TS-1 versus UFT as adjuvant therapy in patients with Stage III colorectal cancer
Region
Japan

Condition
Condition stage III colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate increased activity of TS-1 over UFT as an adjuvant therapy in patients with stage III colorectal cancer. To investigate correlation between mRNA level of enzymes for nucleic acid metabolism in each tumor (TS, DPD, OPRT, TP) and prognosis of patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes 3-year disease free survival
Key secondary outcomes overall survival

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 UFT 400mg/m2/day
5days' medication, 2days' rest
Start medication within 6weeks postoperatively, continue for 12months
Interventions/Control_2 TS-1 80mg/m2/day
28days' medication, 14days' break
Start medication within 6weeks postoperatively, continue for 12months
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 :curatively resected stage III colorectal adenocarcinomas
:performance status 0/1
:no serious postoperative complications
:age not less than 20, not more than 80
:no past history of preoperative treatments, e.g.chemother or radiother.
:written informed consent
Key exclusion criteria :patients with hypersensitivity or allergy to any medicine
:Pts. with myelosupression, renal dysfuction, or liver dysfuncion
:Pts. with severe postoperative complications
:Pt. who is pregnant or is to be pregnant
:Pts. with multiple cancers
:Pts. who are taking other fluoropyrimidine derivatives
:Pts. with severe infection or inflammation
:doctor's decision for exclusion
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisahiro Matsubara
Organization Boso Clinical Oncology Group
Division name The nonprofit organization
Zip code
Address 1-8-1 Inohana, Chuo-Ku, Chiba City, Japan
TEL 043-222-7171
Email matsuhm@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiji Koda
Organization Boso Clinical Oncology Group
Division name The nonprofit organization
Zip code
Address 1-8-1 Inohana, Chuo-Ku, Chiba City, Japan
TEL 043-293-0086
Homepage URL
Email k-koda@umin.ac.jp

Sponsor
Institute Boso Clinical Oncology Group
Institute
Department

Funding Source
Organization The nonprofit organization
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 千葉大学医学部附属病院先端応用外科

Other administrative information
Date of disclosure of the study information
2006 Year 04 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 No longer recruiting
Date of protocol fixation
2005 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 07 Month 01 Day
Last follow-up date
2007 Year 06 Month 01 Day
Date of closure to data entry
2008 Year 02 Month 01 Day
Date trial data considered complete
Date analysis concluded
2013 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 03 Month 02 Day
Last modified on
2016 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000433

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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