UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001560 |
|---|---|
| Receipt number | R000001885 |
| Scientific Title | A randomized phase II trial of adjuvant chemotherapy with UFT/LV versus S-1 following curative resection for stage III colorectal cancer |
| Date of disclosure of the study information | 2008/12/10 |
| Last modified on | 2019/01/28 19:29:22 |
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Basic information
Public title
A randomized phase II trial of adjuvant chemotherapy with UFT/LV versus S-1 following curative resection for stage III colorectal cancer
Acronym
A randomized phase II trial of UFT/LV versus S-1 adjuvant therapy in patients with stage III colorectal cancer
Scientific Title
A randomized phase II trial of adjuvant chemotherapy with UFT/LV versus S-1 following curative resection for stage III colorectal cancer
Scientific Title:Acronym
A randomized phase II trial of UFT/LV versus S-1 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
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of adjuvant chemotherapy with S-1 for curative resection for stage III colorectal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
3-year disease free survival rate
Key secondary outcomes
overall survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
UFT 300mg per m2 per day and LV 75mg per day for 28 days every 5-weeks for 6 months
Interventions/Control_2
TS-1 80mg per m2 per day for 28 days every 6-weeks for 12 months
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. Histological Stage III colorectal adenocarcinoma
2. Resection of histological curability A was performed
3. 20-80 years old
4. No prior chemotherapy and radiotherapy
5. Performance status(ECOG):0 or 1
6. Sufficient organ functions
7. Written informed consent
Key exclusion criteria
1. Severe postoperative complication
2. Serious coexisting illness
1)uncontrolled diabetes mellitus and hypertension
2)history of myocardial infarction, unstable angina within 6 months prior to the registrationsevere
3)pulmonary dysfunction
3. Active diarrhea
4. Multiple cancer
5. Pregnant
6. Disqualified by attending doctor
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiji Koda |
Organization
Teikyo University Chiba Medical Center
Division name
Department of surgery
Zip code
Address
3426-3 Anegasaki, Ichihara, Japan
TEL
0436-62-1211
k-koda@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyauchi |
Organization
Graduate school of medicine
Division name
Department of frontier surgery
Zip code
Address
1-8-1 Inohana, Chu0-ku, Chiba, Japan
TEL
043-226-2109
Homepage URL
miyahide@faculty.chiba-u.jp
Sponsor or person
Institute
Boso Clinical Oncology Group
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 12 | Month | 10 | 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
| 2008 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 09 | Day |
Last modified on
| 2019 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001885
