UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized phase II trial of adjuvant chemotherapy with UFT/LV versus S-1 following curative resection for stage III colorectal cancer
Title of the study (Brief title)	A randomized phase II trial of UFT/LV versus S-1 adjuvant therapy in patients with stage III colorectal cancer
Region	Japan

Condition
Condition	stage III colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of adjuvant chemotherapy with S-1 for curative resection for stage III colorectal cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	3-year disease free survival rate
Key secondary outcomes	overall survival

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	UFT 300mg per m2 per day and LV 75mg per day for 28 days every 5-weeks for 6 months
Interventions/Control_2	TS-1 80mg per m2 per day for 28 days every 6-weeks for 12 months
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. Histological Stage III colorectal adenocarcinoma 2. Resection of histological curability A was performed 3. 20-80 years old 4. No prior chemotherapy and radiotherapy 5. Performance status(ECOG):0 or 1 6. Sufficient organ functions 7. Written informed consent
Key exclusion criteria	1. Severe postoperative complication 2. Serious coexisting illness 1)uncontrolled diabetes mellitus and hypertension 2)history of myocardial infarction, unstable angina within 6 months prior to the registrationsevere 3)pulmonary dysfunction 3. Active diarrhea 4. Multiple cancer 5. Pregnant 6. Disqualified by attending doctor
Target sample size	140

Research contact person
Name of lead principal investigator	Keiji Koda
Organization	Teikyo University Chiba Medical Center
Division name	Department of surgery
Address	3426-3 Anegasaki, Ichihara, Japan
TEL	0436-62-1211
Email	k-koda@med.teikyo-u.ac.jp

Public contact
Name of contact person	Hideaki Miyauchi
Organization	Graduate school of medicine
Division name	Department of frontier surgery
Address	1-8-1 Inohana, Chu0-ku, Chiba, Japan
TEL	043-226-2109
Homepage URL
Email	miyahide@faculty.chiba-u.jp

Sponsor
Institute	Boso Clinical Oncology Group
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)

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	2008 Year 12 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 02 Month 27 Day
Anticipated trial start date	2008 Year 03 Month 01 Day
Last follow-up date	2013 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2008 Year 12 Month 09 Day
Last modified on	2019 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001885