UMIN-CTR Clinical Trial

Basic information
Public title	Clinical stusy of induction S-1+Oxaliplatin+/-Cetuximab chemotherapy followed by short-course chemoradiotherapy in locally advanced ugly rectal cancer
Acronym	Clinical stusy of induction S-1+Oxaliplatin+/-Cetuximab chemotherapy followed by short-course chemoradiotherapy in locally advanced ugly rectal cancer
Scientific Title	Clinical stusy of induction S-1+Oxaliplatin+/-Cetuximab chemotherapy followed by short-course chemoradiotherapy in locally advanced ugly rectal cancer
Scientific Title:Acronym	Clinical stusy of induction S-1+Oxaliplatin+/-Cetuximab chemotherapy followed by short-course chemoradiotherapy in locally advanced ugly rectal cancer
Region	Japan

Condition
Condition	locally advanced rectal cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	safety and efficiency of induction chemotherapy(TS-1/L-OHP+/- Cetuximab) followed by chemoradiotherapy and surgery in locally advanced rectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	pathologival complete response rate
Key secondary outcomes	Adverse event Compliance to induction chemotherapy R0 resection rate Down-staging rate(T,N stage) Tumor regression grade LFS; local recurrence free survival RFS; Recurrence free survival OS; Overall survival

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	S-1/Oxaliplatin; treatment dose was decided by body mass index Cetuximab was used only Kras wild type
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1) T3 lower rectal cancer with mesorectal fascia involvement 2) T4a or T4b tumors 3) lateral lymph node swelling with the cut-off size larger 5mm measured on axial view at shorter axis.
Key exclusion criteria	inflammatory bowel disease cardiac disease medical conditions that would not permit the patient to complete the study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hidenori Yanagi
Organization	Meiwa Hospital
Division name	Surgery
Zip code
Address	4-31 Agenaruo-cho, Nishinomiya, Hyogo
TEL	+81-798-47-1767
Email	n_beppu@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Naohito Beppu
Organization	Meiwa Hospital
Division name	Surgery
Zip code
Address	4-31 Agenaruo-cho, Nishinomiya, Hyogo
TEL	+81-798-47-1767
Homepage URL
Email	n_beppu@yahoo.co.jp

Sponsor
Institute	Meiwa Hospital department of 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)

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	明和病院(兵庫県)

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 01 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	Open public recruiting
Date of protocol fixation	2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 05 Month 28 Day
Last modified on	2015 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020527

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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