UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007696 |
|---|---|
| Receipt number | R000008994 |
| Scientific Title | A randomized phase II study of UFT/LV or TEGAFOX for patient with curatively resected high risk Stage II and Stage III colorectal cancer. |
| Date of disclosure of the study information | 2012/04/10 |
| Last modified on | 2020/04/15 14:16:50 |
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Basic information
Public title
A randomized phase II study of UFT/LV or TEGAFOX for patient with curatively resected high risk Stage II and Stage III colorectal cancer.
Acronym
SOAC-1101
Scientific Title
A randomized phase II study of UFT/LV or TEGAFOX for patient with curatively resected high risk Stage II and Stage III colorectal cancer.
Scientific Title:Acronym
SOAC-1101
Region
| Japan |
Condition
Condition
high risk stage II/ stage III colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of UFT/Leucovorin and UFT/Leucovorin/Oxaliplatin in patient with curatively resected high risk stage II/ stage III colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3-year desiese free survival rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
UFT(300mg/m2)+LV(75mg) /day, orally 4 weeks on and 1 week off in each corse. Total 5 weeks.
Interventions/Control_2
UFT(300mg/m2)+LV(75mg) /day, orally 4 weeks on and 1 week off in each corse. Total 5 weeks.
Oxaliplatin gives 85 mg/m2 intravenously on 1,15 day of each course.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Confirmed adenocarcinoma
2) High risk stage II or stage III colorectal cancer
3) Recieved curative resction
4) 20 years old or older
5) PS(ECOG) 0 or 1
6) No previous treatment exclude surgery
7) Oral intake is possible
8) Adequate organ fanction
9) Treatment can start within eight weeks after surgery.
10) Written informed consent
Key exclusion criteria
1) Serious diarrea
2) Serious postoperative complications
3) Serious drug hypersensitivity
4) Pregnant or nursing
5) Serious coexisting illness
1; diabetes mellitus, uncontrolled or controlled with insulin
2; uncontrolled hypertension
3; liver cirrhosis
4; renal disfaunction
5; severe pulmonary dysfunction
6; active infection
7; history of myocardial infarction, unstable angina within 6 months prior to the registration
6) Active synchronous or metachronous malignancy other than carcinoma in situ
7) Sensory neuropathy
8) Severe mental disorders
9) Not suitable for participating in the study for any other reason
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hisahiro |
| Middle name | |
| Last name | Matsubara |
Organization
Chiba University Hospital
Division name
Esophageal-Gastro-Intestinal Surgery
Zip code
260-8677
Address
1-8-1Inohana, chuo-ku, Chiba-shi, Chiba
TEL
043-226-2109
matsuhm@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | MIyauchi |
Organization
Chiba surgical oncology development association
Division name
The secretariat
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-226-2109
Homepage URL
miyahide@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba surgical oncology development association
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
Chiba University Certified Clinical Research Review Board
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Chiba
Tel
043-226-2616
prc-jim@chiba-u.jp
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
| 2012 | Year | 04 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 09 | Day |
Last modified on
| 2020 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008994
