UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006790 |
|---|---|
| Receipt number | R000007903 |
| Scientific Title | Phase2 study of perioperative chemotherapy with SOX and operation for Stage3 colorectal cancer(SOS3) |
| Date of disclosure of the study information | 2011/11/30 |
| Last modified on | 2019/05/23 16:10:21 |
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Basic information
Public title
Phase2 study of perioperative chemotherapy with SOX and operation for Stage3 colorectal cancer(SOS3)
Acronym
FUTURE1104(SOS3)
Scientific Title
Phase2 study of perioperative chemotherapy with SOX and operation for Stage3 colorectal cancer(SOS3)
Scientific Title:Acronym
FUTURE1104(SOS3)
Region
| Japan |
Condition
Condition
Resectable Colorectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficasy with Stage3 patients for resectable colorectal cancer using TS-1 plus Oxaliplatin(SOX) therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate,Safety
Key secondary outcomes
The complete rate of treatment ,Disease free survival time
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oxaliplatin 130mg/m2i.v.(day1)
TS-1 80mg/m2 p.o.(day1-14)
drug holidays (day15-21)
to be repeated every 3 weeks
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.Stage3 for resectable colorectal cancer
patients
2.Possible case using SOX therapy before and after surgery.
3.No prior chemotherapy
4.Age:20 years to 80 years
5.Performance Status:0-1(ECOG criteria)
6.Signed written informed consent
7.Vital organ functions are preserved within 14days prior to entry
WBC:>3,000 and=<12,000/mm3
Neutrophil:>=1,500/mm3
Platelet:>=100,000/mm3
Hemoglobin content:>9.0g/dl
Creatinin:<=1.5mg/dl
Creatinin clearerance:>=50ml/mim
AST,ALT:<=100IU
T.bil:<1.5mg/dl
Key exclusion criteria
1.Prior severe drug allergy
2.Nursing or pregnant females,or females or mailes with female partners who are planning pregnancy
3.Presence of active infection
4.Serious complications(Such as ileus,
uncontrolled diabetes and so on)
5.Inadequate for study enrollment by the physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichiro Yoshida |
Organization
Fukuoka University Faculty of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
7-45-1,Nanakuma,Johnan-ku,Fukuoka,814-0180,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichiro Yoshida |
Organization
Fukuoka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
7-45-1,Nanakuma,Johnan-ku,Fukuoka,814-0180,Japan
TEL
Homepage URL
Sponsor or person
Institute
Fukuoka Tumor Research(FUTURE)
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
福岡大学医学部消化器外科学
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 30 | 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
| 2011 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2011 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 29 | Day |
Last modified on
| 2019 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007903
