UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011750
Receipt number R000013725
Scientific 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
Date of disclosure of the study information 2013/09/13
Last modified on 2017/11/24 14:24:18

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Basic information

Public 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

Acronym

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

Scientific 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

Scientific Title:Acronym

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

1st name
Middle name
Last name Masahiko Watanabe

Organization

Kitasato University

Division name

Department of Surgery

Zip code


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

1st name
Middle name
Last name Masaaki Ito

Organization

National Cancer Center Hospital East

Division name

Colorectal Surgery

Zip code


Address

6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan

TEL

04-7133-1111

Homepage URL


Email

maito@east.ncc.go.jp


Sponsor or person

Institute

Japanese Society for Cancer of the Colon and Rectum

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 13 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

No longer recruiting

Date of protocol fixation

2013 Year 08 Month 23 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013725


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name