Brief Summary

The purpose of this study is to evaluate oncological outcome of patients for T3 and T4 colorectal cancer undergoing laparoscopic versus open surgery.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,050

participants targeted

Target at P75+ for phase_3 colorectal-cancer

Timeline

Completed

Started Nov 2004

Longer than P75 for phase_3 colorectal-cancer

Geographic Reach

1 country

26 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.3 years study duration

Study Start

First participant enrolled

November 1, 2004

Completed

10 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2005

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed

8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed

Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

9.3 years

First QC Date

September 5, 2005

Last Update Submit

September 20, 2016

Conditions

Colorectal Cancer

Keywords

colorectal cancerlaparoscopic surgeryrandomized controlled trialoncological outcome

Outcome Measures

Primary Outcomes (1)

Overall survival
During the study conduct

Secondary Outcomes (5)

Relapse-free survival
During the study conduct
Short-term clinical outcomes
time to 1st discharge after operation
Adverse events
During the study conduct
The proportion of conversion from LAP to OPEN
operation day
The proportion of completion of LAP
operation day

Study Arms (2)

1

ACTIVE COMPARATOR

Procedure/Surgery: open colectomy

Procedure: open colectomy

2

EXPERIMENTAL

Procedure/Surgery: laparoscopic colectomy

Procedure: laparoscopic colectomy

Interventions

open colectomyPROCEDURE

Procedure/Surgery: open colectomy

laparoscopic colectomyPROCEDURE

Procedure/Surgery: laparoscopic colectomy

Eligibility Criteria

Age20 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically proven colorectal carcinoma
Tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon
T3 or deeper lesion without involvement of other organs
Without multiple lesion other than carcinoma in situ
Cancer classified as N0-2 and M0, according to the TNM classification system
Tumor size \< 8 cm
No bowel obstruction
Age 20 \< and \> 75 years
Sufficient organ function
No history of gastrointestinal surgery
No history of chemotherapy or radiotherapy
Provided written informed consent

You may not qualify if:

Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
Severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease
Pregnant or lactating women
Severe mental disease
Continuous systemic steroid therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Haruhiko Fukudalead
Ministry of Health, Labour and Welfare, Japancollaborator

Study Sites (26)

Fujita Health University

Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, 470-1192, Japan

Location

National Cancer Center Hospital East

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

Location

Toho University Sakura Hospital

Sakura,Shimoshidu,564-1, Chiba, 285-8741, Japan

Location

Jyuntendo Urayasu Hospital

Urayasu,Tomioka,2-1-1, Chiba, 279-0021, Japan

Location

National Hospital Organization Shikoku Cancer Center

Matsuyama,Horinouchi,13, Ehime, 790-0007, Japan

Location

Kurume University School of Medicine

Kurume,Asahi-machi,67, Fukuoka, 830-0011, Japan

Location

Hiroshima University, School of Medicine

Hiroshima,Minami-ku,Kasumi,1-2-3, Hiroshima, 734-8551, Japan

Location

Ishikawa Prefectual Central Hospital

Kanazawa,Kuratsuki-Higashi,2-1, Ishikawa-ken, 920-8530, Japan

Location

Teikyo University Hospital, Mizonokuchi

Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3, Kanagawa, 213-8507, Japan

Location

Kitasato University East Hospital

Sagamihara,Asamizodai,2-1-1, Kanagawa, 228-8520, Japan

Location

Kitasato University School of Medichine

Sagamihara,Kitasato,1-15-1, Kanagawa, 228-8555, Japan

Location

Showa University Northern Yokohama Hospital

Yokohama,Tsuzuki-ku,Chigasakichuo,35-1, Kanagawa, 224-8503, Japan

Location

National Hospital Organization Kyoto Medical Center

Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1, Kyoto, 612-8555, Japan

Location

Nagano Municipal Hospital

Nagano,Tomitake,1333-1, Nagano, 381-8551, Japan

Location

Oita University Faculty of Medicine

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

Location

Osaka City General Hospital

Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, 534-0021, Japan

Location

Osaka University Graduate School of Medicine

Suita,Yamada-oka,2-2, Osaka, 565-0871, Japan

Location

Osaka Medical College

Takatsuki,Daigakucho,2-7, Osaka, 569-0801, Japan

Location

Omiya Medical Center, Jichi Medical School

Saitama,Omiya-ku,Amanuma-cho,1-847, Saitama, 330-8503, Japan

Location

Sizuoka Cancer Center

Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, 411-8777, Japan

Location

Tokyo Medical and Dental University Hospital

Bunkyo-ku,Yushima,1-5-45, Tokyo, 113-8519, Japan

Location

National Cancer Center Hospital

Chuo-ku,Tsukiji,5-1-1, Tokyo, 104-0045, Japan

Location

Toho University Ohashi Hospital

Meguro-ku,Ohashi,2-17-6, Tokyo, 153-0044, Japan

Location

Toranomon Hospital

Minato-ku,Toranomon,2-2-2, Tokyo, 105-8470, Japan

Location

Kyorin University School of Medicine

Mitaka,Shinkawa,6-20-2, Tokyo, 181-8611, Japan

Location

Keio University Hospital

Shinjuku-ku,Shinanomachi,35, Tokyo, 160-8582, Japan

Location

Related Publications (5)

Saito S, Akagi T, Katayama H, Wakabayashi M, Inomata M, Yamamoto S, Ito M, Kinugasa Y, Egi H, Munakata Y, Kokuba Y, Bando H, Yasui M, Ikeda M, Nakajima K, Shida D, Kanemitsu Y, Kitano S; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Identification of patient subgroups with unfavorable long-term outcomes associated with laparoscopic surgery in a randomized controlled trial comparing open and laparoscopic surgery for colon cancer (Japan Clinical Oncology Group Study JCOG0404). Ann Gastroenterol Surg. 2021 Aug 9;5(6):804-812. doi: 10.1002/ags3.12475. eCollection 2021 Nov.
PMID: 34755012DERIVED
Nishizawa Y, Akagi T, Inomata M, Katayama H, Mizusawa J, Yamamoto S, Ito M, Masaki T, Watanabe M, Shimada Y, Kitano S. Risk factors for early postoperative complications after D3 dissection for stage II or III colon cancer: Supplementary analysis of a multicenter randomized controlled trial in Japan (JCOG0404). Ann Gastroenterol Surg. 2019 Apr 4;3(3):310-317. doi: 10.1002/ags3.12246. eCollection 2019 May.
PMID: 31131360DERIVED
Fujii S, Akagi T, Inomata M, Katayama H, Mizusawa J, Ota M, Saito S, Kinugasa Y, Yamaguchi S, Sato T, Kitano S; Japan Clinical Oncology Group. Transitional impact of short- and long-term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404. Ann Gastroenterol Surg. 2019 Mar 26;3(3):301-309. doi: 10.1002/ags3.12245. eCollection 2019 May.
PMID: 31131359DERIVED
Kitano S, Inomata M, Mizusawa J, Katayama H, Watanabe M, Yamamoto S, Ito M, Saito S, Fujii S, Konishi F, Saida Y, Hasegawa H, Akagi T, Sugihara K, Yamaguchi T, Masaki T, Fukunaga Y, Murata K, Okajima M, Moriya Y, Shimada Y. Survival outcomes following laparoscopic versus open D3 dissection for stage II or III colon cancer (JCOG0404): a phase 3, randomised controlled trial. Lancet Gastroenterol Hepatol. 2017 Apr;2(4):261-268. doi: 10.1016/S2468-1253(16)30207-2. Epub 2017 Feb 2.
PMID: 28404155DERIVED
Yamamoto S, Inomata M, Katayama H, Mizusawa J, Etoh T, Konishi F, Sugihara K, Watanabe M, Moriya Y, Kitano S; Japan Clinical Oncology Group Colorectal Cancer Study Group. Short-term surgical outcomes from a randomized controlled trial to evaluate laparoscopic and open D3 dissection for stage II/III colon cancer: Japan Clinical Oncology Group Study JCOG 0404. Ann Surg. 2014 Jul;260(1):23-30. doi: 10.1097/SLA.0000000000000499.
PMID: 24509190DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

Seigo Kitano, MD, PhD,FACS
Oita University
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: JCOG Data Center

Study Record Dates

First Submitted

September 5, 2005

First Posted

September 7, 2005

Study Start

November 1, 2004

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

September 22, 2016

Record last verified: 2016-09

Locations

JP(26)

A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (26)

Related Publications (5)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (26)

Related Publications (5)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations