UMIN-CTR Clinical Trial

Basic information
Public title	A multi center, phase 3 study to evaluate safety and efficacy of extensive intraoperative peritoneal lavage, that project to prevent recurrence, in the laparoscopic surgery for advanced colon cancer
Acronym	SENJYO study
Scientific Title	A multi center, phase 3 study to evaluate safety and efficacy of extensive intraoperative peritoneal lavage, that project to prevent recurrence, in the laparoscopic surgery for advanced colon cancer
Scientific Title:Acronym	SENJYO study
Region	Japan

Condition
Condition	locally advanced colon cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of extensive intraoperative peritoneal lavage in the laparoscopic surgery for advanced colon cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relapse free survival of pathological T4 and/or N2 cases
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	In the treatment group, surgeons perform EIPL (extensive intraoperative peritoneal lavage).
Interventions/Control_2	In the control group, surgeons perform peritonel lavage with less than 1L of saline.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Written consent to participate in the study has been obtained from the patient. 2) Performance Status (ECOG) of either 0 or 1. 3) Patient has operable general condition and organ function. 4) Patients with scheduled laparoscopic surgery for locally advanced colon cancer.
Key exclusion criteria	1) Patients with history of surgery within 4weeks 2) Patients with multiple cancers
Target sample size	2600

Research contact person
Name of lead principal investigator	1st name Mamoru Middle name Last name Uemura
Organization	Osaka University, Graduate School of Medicine
Division name	Departments of Gastroenterological surgery
Zip code	565-0871
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3251
Email	muemura@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Takahashi
Organization	National Hospital Organization Osaka National Hospital
Division name	Department of Surgery
Zip code	540-0006
Address	2-1-14 Hoenzaka, Chuo-ku, Osaka
TEL	06-6942-1331
Homepage URL
Email	takahashi.yusuke.eu@mail.hosp.go.jp

Sponsor
Institute	Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment 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)

IRB Contact (For public release)
Organization	Osaka University, Graduate School of Medicine
Address	2-2 Yamadaoka, Suita, Osaka
Tel	06-6210-8290
Email	jim-chiken@hp.crc.med.osaka-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	2022 Year 07 Month 26 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	Preinitiation
Date of protocol fixation	2022 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date	2022 Year 08 Month 01 Day
Last follow-up date	2028 Year 08 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	2022 Year 07 Month 25 Day
Last modified on	2022 Year 07 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055224