UMIN-CTR Clinical Trial

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
Email	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
Email	miyahide@faculty.chiba-u.jp

Sponsor
Institute	Chiba surgical oncology development association
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	Chiba University Certified Clinical Research Review Board
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Chiba
Tel	043-226-2616
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008994