UMIN-CTR Clinical Trial

Public title

Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Colorectal Cancer(JCOG 0404,CRC Surg-LAP/OPEN)

Acronym

Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Colorectal Cancer(JCOG 0404,CRC Surg-LAP/OPEN)

Scientific Title

Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Colorectal Cancer(JCOG 0404,CRC Surg-LAP/OPEN)

Scientific Title:Acronym

Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Colorectal Cancer(JCOG 0404,CRC Surg-LAP/OPEN)

Region

Japan

Condition

Colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate oncological outcome of patients for T3 and T4 colorectal cancer undergoing laparoscopic versus open surgery

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

overall survival

Key secondary outcomes

relapse-free survival, short-term clinical outcomes, adverse events, the proportion of conversion from LAP to OPEN, the proportion of completion of LAP

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Surgery:open colectomy

Interventions/Control_2

Surgery:laparoscopic colectomy

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

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

For inclusion in the study, patients must fulfill the following requirements preoperatively:
(1) histologically proven colorectal carcinoma
(2) tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon
(3) T3 or deeper lesion without involvement of other organs
(4)without multiple lesion other than carcinoma in situ
(5) cancer classified as N0-2 and M0, according to the TNM classification system
(6) tumor size < 8 cm
(7) no bowel obstruction
(8) age 20< and >75 years
(9) sufficient organ function
(10) no history of gastrointestinal surgery
(11) no history of chemotherapy or radiotherapy
(12) provided written informed consent

Key exclusion criteria

Exclusion criteria are as follows:
(1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
(2) severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease
(3) pregnant or lactating women
(4) severe mental disease
(5) continuous systemic steroid therapy

Target sample size

818

Name of lead principal investigator

1st name
Middle name
Last name	Seigo Kitano, MD, PhD

Organization

Oita University Faculty of Medicine

Division name

Gastroenterological Surgery

Zip code

Address

1-1 Hasama-machi, Yufu city, Oita, 879-5593, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Masafumi Inomata, MD

Organization

JCOG0404 Coordinating Office

Division name

Oita University Faculty of Medicine

Zip code

Address

1-1 Hasama-machi, Yufu city, Oita, 879-5593, Japan

TEL

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

NCT00147134

Org. issuing International ID_1

ClinicalTrials.gov by NLM

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

岩手医科大学（岩手県）
埼玉県立がんセンター（埼玉県）
自治医科大学附属さいたま医療センター（埼玉県）
国立がん研究センター東病院（千葉県）
順天堂浦安病院（千葉県）
国立がん研究センター中央病院（東京都）
杏林大学医学部（東京都）
慶應義塾大学病院（東京都）
東京医科歯科大学（東京都）
東邦大学医療センター大橋病院（東京都）
北里大学東病院（神奈川県）
北里大学医学部（神奈川県）
昭和大学横浜市北部病院（神奈川県）
横浜市立大学附属市民総合医療センター（神奈川県）
石川県立中央病院（石川県）
長野市民病院（長野県）
静岡県立静岡がんセンター（静岡県）
藤田保健衛生大学（愛知県）
国立病院機構京都医療センター（京都府）
国立病院機構大阪医療センター（大阪府）
市立吹田市民病院（大阪府）
広島大学病院（広島県）
国立病院機構四国がんセンター（愛媛県）
久留米大学医学部（福岡県）
大分大学医学部附属病院（大分県）

Date of disclosure of the study information

2005

Year

09

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/28404155

Number of participants that the trial has enrolled

Results

See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html

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

Completed

Date of protocol fixation

2004

Year

09

Month

17

Day

Date of IRB

Anticipated trial start date

2004

Year

11

Month

01

Day

Last follow-up date

2012

Year

10

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2005

Year

09

Month

01

Day

Last modified on

2017

Year

07

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000154