UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of irinotecan, S-1 and oxaliplatin in combination with radiation therapy in patients with advanced rectal cancer
Title of the study (Brief title)	Phase I study of irinotecan, S-1 and oxaliplatin in combination with radiation therapy in patients with advanced rectal cancer
Region	Japan

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

Objectives
Narrative objectives1	To determine the DLT, MTD and RD of oxaliplatin in combination regimen of irinotecan/S-1/oxaliplatin and preoperative radiotherapy for advanced rectal cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MTD,DLT,RD
Key secondary outcomes

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 80mg/m2, irinotecan 40mg/m2, oxaliplatin dose level 1-3
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 rectal adenocarcinoma 2)T3 or T4 or N1-3 disease 3)ECOG PS 0-1 4)Expectation of over 3 months survival 5)Patients with adequate main organ function 6)Patient with written informed consent
Key exclusion criteria	1)Previous history of drug-induced allergy 2)Pregnant of lactating and woman with childbearing potential who lacked effective contaception 3)Man who lacked effective contraception 4)With uncontrolled renal failure 5)With uncontrolled heart disease 6)With severe plumonary disease 7)With gastrointestinal bleeding, obstruction, perforation 8)With active inflammatory bowel disease 9)With active infection 10)With large amount of ascites, pleural effusion, or pericardial effusion 11)Any other cases who are regarded as inadequate for study enrollment by the investigator
Target sample size	12

Research contact person
Name of lead principal investigator	Yasuhiro Inoue
Organization	Mie University Graduate School of Medicine
Division name	Department of Gastrointestinal and Pediatric Surgery, Division of Reparative Medicine, Institute of Life Sciences
Address	2-174 Edobashi, Tsu, Mie, 514-8507, Japan
TEL	059-232-1111
Email	yasinoue@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Yasuhiro Inoue
Organization	Mie University Graduate School of Medicine
Division name	Department of Gastrointestinal and Pediatric Surgery
Address	2-174 Edobashi, Tsu, Mie, 514-8507, Japan
TEL	059-232-1111
Homepage URL
Email	yasinoue@clin.medic.mie-u.ac.jp

Sponsor
Institute	Department of Gastrointestinal and Pediatric Surgery, Division of Reparative Medicine, Institute of Life Sciences, Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Gastrointestinal and Pediatric Surgery, Division of Reparative Medicine, Institute of Life Sciences, Mie University Graduate School of Medicine
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	2015 Year 05 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 15 Day
Anticipated trial start date	2015 Year 05 Month 27 Day
Last follow-up date
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	2015 Year 05 Month 25 Day
Last modified on	2018 Year 08 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020488