UMIN-CTR Clinical Trial

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
Last 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
1st 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