UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective Phase II Trial of Laparoscopic Surgery for Ultra-low Rectal Cancers within Five Centimeters from the Anus or Three Centimeters from the Dentate Line
Title of the study (Brief title)	Prospective Phase II Trial of Laparoscopic Surgery for Ultra-low Rectal Cancers within Five Centimeters from the Anus or Three Centimeters from the Dentate Line
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to prospective research outcome of lparoscopic surgery for low rectal cancer and frequency of defecation, urinary and sexual dysfunction using international index.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Local recurrence in three years
Key secondary outcomes	1, Recurrence free survival 2, Overall survival 3, Defecation, urinary and sexualfunction , QOL 4, Rate of anal preservation 5, Adverse effect

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Histologically confirmed adenocarcinoma of the rectum 2.Lower border of the tomor is within five centimeter from the anus or three cemtimeter from the dentate line 3.c-T1-2N0M0 stage I(TNM7th) 4.Aged 20 years old or over 5.Possible to curative resection 6.Operable general status and organ function 7.PS(ECOG) of 0 or 1 8.No prior chemotherapy or radiation therapy. 9.Written informed consent
Key exclusion criteria	1.Hope for laparotomy 2.Preoperative severe disorder of anal function and supposed postoperative disorder 3.Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma. 4.Uncontrollable diabetes mellitus or hypertension. Interstitial lung disease, pulmonary fibrosis or severe emphysema. 5.Severe mental disease. 6.Impossible to written informed consent 7.Doctor' s decision for exclusion
Target sample size	300

Research contact person
Name of lead principal investigator	Masahiko Watanabe
Organization	Kitasato University
Division name	Department of Surgery
Address	1-15-1, Kitasato, Sagamihara, Kanagawa, Japan 252-0374
TEL	042-778-8111
Email	geka@med.kitasato-u.ac.jp

Public contact
Name of contact person	Masaaki Ito
Organization	National Cancer Center Hospital East
Division name	Colorectal Surgery
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
TEL	04-7133-1111
Homepage URL
Email	maito@east.ncc.go.jp

Sponsor
Institute	Japanese Society for Cancer of the Colon and Rectum
Institute
Department

Funding Source
Organization	National Cancer Center Hospital East
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Ishikawa Prefectural Central Hospital, Imate Medical University, Ehime Prefectural Central Hospital, Oita University, Osaka University, Osaka Medical University, Osaka Red Cross Hospital, Osaka Rosai Hospital, Kagawa Prefectural Central Hospital, Kagawa University, Kawasaki Medical University, The Cancer Institute Hospital of JFCR, Kansai Rosai Hospital, Kitasato University, Kyushu University, Kyoto University, Kyoto Medical Center, Kyoto Prefectural University of Medicine, Kyorin University, Kinki University, Keio University, Kochi Health Sciences Center, Kochi University, National Cancer Cen
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	2013 Year 09 Month 13 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 08 Month 23 Day
Anticipated trial start date	2013 Year 11 Month 01 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	We will examine the outcome of laparoscopic surgery for low rectal cancer and the defecation, urinary and sexual dysfunction by prospective study.

Management information
Registered date	2013 Year 09 Month 13 Day
Last modified on	2017 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013725