UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000346 |
|---|---|
| Receipt number | 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 20:04:30 |
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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
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
k-koda@umin.ac.jp
Sponsor or person
Institute
Boso Clinical Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000433
