UMIN-CTR Clinical Trial

Basic information
Public title	Phase2 trial of neoadjuvant chemotherapy with S-1 plus radiation in patients with locally advanced rectal cancer
Acronym	Phase2 trial of neoadjuvant chemotherapy with S-1 plus radiation in patients with locally advanced rectal cancer
Scientific Title	Phase2 trial of neoadjuvant chemotherapy with S-1 plus radiation in patients with locally advanced rectal cancer
Scientific Title:Acronym	Phase2 trial of neoadjuvant chemotherapy with S-1 plus radiation in patients with locally advanced rectal cancer
Region	Japan

Condition
Condition	Low rectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to establish the feasibility and efficacy of preoperative radiation with TS-1 in patients with locally advance rectal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Rate of pathological complete response
Key secondary outcomes	Safety

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	TS-1:80mg/m2-120mg/m2 day1-5,8-12,15-19,22-26,29-33 Radiation:1.8Gy of consecutive 5days, Total dose 45 Gy
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.Histologically confirmed low Rectum adenocarcinoma(without Rs) 2.Preoperative CT or MRI findings the clinical stage is T3-4 and any N 3.Recectable 4.No evidence of peritoneal metastasis, liver metastasis and distant metastasis. 5.age:20-80years old 6.Performance status 0-1 7.Without prior anti-tumor therapy 8. Adequate organ function 9.the case can eat 10.Written IC
Key exclusion criteria	1.Impossible to receive TS-1 contained chemotherapy 2.Recieving the radiation therapy in a pelvis 3.Infection 4.Serious complications 5.Myocardial infarction within the last 6 months, previous serious medical illness or allergy for drug 6.Multiple malignancies 7. Pleural effusion or ascites requiring 8.Current or previous Brain metastasis 9.Diarrhea(watery stool) 10.Fresh bleeding of digestive organs 11.Need to treatment with flucytosine, atazanavir sulfate, or warfalin 12.Evidence of psychiatric disability interfering with enrollment to clinical trial 13.Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant 14.Man of wanting child 15.Need Systemically administration of corticosteroids 16.Patients judged inappropriate for this study by the physicians
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kimihiko Middle name Last name Funahashi
Organization	Toho University School of Medicine
Division name	Division of general and gastroenterological surgery, Department of Surgery (Omori)
Zip code	143-8541
Address	6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541. Japan
TEL	03-3762-4151
Email	kingkong@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Kimihiko Middle name Last name Funahashi
Organization	Division of general and gastroenterological surgery, Department of Surgery (Omori)
Division name	Division of general and gastroenterological surgery, Department of Surgery (Omori)
Zip code	143-8541
Address	6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541. Japan
TEL	03-3762-4151
Homepage URL
Email	kingkong@med.toho-u.ac.jp

Sponsor
Institute	Toho University School of Medicine
Institute
Department

Funding Source
Organization	Toho University
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	Toho University Omori Medical Center
Address	6-11-1 Omorinishi Ota-ku Tokyo, Japan
Tel	03-3762-4151
Email	kingkong@med.toho-u.ac.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	2014 Year 04 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	Completed
Date of protocol fixation	2012 Year 02 Month 01 Day
Date of IRB	2015 Year 06 Month 03 Day
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date	2018 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 04 Month 01 Day
Last modified on	2019 Year 11 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015887