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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006790
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Fukuoka Tumor Research(FUTURE)
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007903

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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