UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preoperative chemoradiotherapy with oral S-1 and UFT/LV for stage II/III rectal cancer. Clinical significance of additional systemic chemotherapy before surgery.
Title of the study (Brief title)	Preoperative chemoradiotherapy with oral S-1 and UFT/LV for stage II/III rectal cancer.
Region	Japan

Condition
Condition	Stage II /Stage III rectal cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	developement of an optimal preoperative chemoradiotherapy for rectal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	rate of pCR (pathological complete regression)
Key secondary outcomes	Tumor regression grading, rate of R0 resection, rate of daownstaging, Disease-free survival, 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	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Standard therapy group 1 (4 weeks of S-1)
Interventions/Control_2	Trial therapy group 1 (8 weeks of S-1)
Interventions/Control_3	Standard therapy group 2 (5 weeks of UFT/LV)
Interventions/Control_4	Trial therapy group 2 (10 weeks of UFT/LV)
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	clinical Stage II/III rectal cancer
Key exclusion criteria	emergency surgery
Target sample size	60

Research contact person
Name of lead principal investigator	Sotaro Sadahiro
Organization	Tokai University
Division name	gastrointestinal surgery
Address	143 Shimokasuya Isehara
TEL	0463-93-1121
Email	sadahiro@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	Sotaro Sadahiro
Organization	Tokai University
Division name	Gastrointestinal Surgery
Address	143 Shimokasuya Isehara
TEL	0463-93-1121
Homepage URL
Email	sadahiro@is.icc.u-tokai.ac.jp

Sponsor
Institute	Tokai University, Department of Gastrointestinal Surgery
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	東海大学付属病院 (神奈川県)

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 30 Day
Anticipated trial start date	2013 Year 10 Month 29 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry	2016 Year 09 Month 30 Day
Date trial data considered complete	2016 Year 09 Month 30 Day
Date analysis concluded	2017 Year 03 Month 31 Day

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

Management information
Registered date	2014 Year 03 Month 24 Day
Last modified on	2018 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015766