UMIN-CTR Clinical Trial

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

Rectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Japanese Society for Cancer of the Colon and Rectum

Institute

Department

Personal name

Organization

National Cancer Center Hospital East

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

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)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

09

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

We will examine the outcome of laparoscopic surgery for low rectal cancer and the defecation, urinary and sexual dysfunction by prospective study.

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