A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

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

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: open colectomy; Procedure: laparoscopic colectomy

Detailed Description

The benefits of laparoscopic surgery (LAP) in comparison to open surgery (OPEN) have been suggested with respect to decreased morbidity, decreased pain, faster recovery, and shorter hospital stay.1-4 However, the long-term survival of LAP for colorectal cancer is still unclear, especially for advanced colorectal cancer requiring extended lymphadenectomy. Thus, the investigators designed a study which investigates whether LAP is suitable for advanced colorectal cancer with respect to survival and post-operative morbidity.

• Study Type: Interventional
• Enrollment (Actual): 1050
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi, Japan, 470-1192
      • Fujita Health University
  • Chiba
    • Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
    • Sakura,Shimoshidu,564-1, Chiba, Japan, 285-8741
      • Toho University Sakura Hospital
    • Urayasu,Tomioka,2-1-1, Chiba, Japan, 279-0021
      • Jyuntendo Urayasu Hospital
  • Ehime
    • Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007
      • National Hospital Organization Shikoku Cancer Center
  • Fukuoka
    • Kurume,Asahi-machi,67, Fukuoka, Japan, 830-0011
      • Kurume University School of Medicine
  • Hiroshima
    • Hiroshima,Minami-ku,Kasumi,1-2-3, Hiroshima, Japan, 734-8551
      • Hiroshima University, School of Medicine
  • Ishikawa
    • Kanazawa,Kuratsuki-Higashi,2-1, Ishikawa, Japan, 920-8530
      • Ishikawa Prefectual Central Hospital
  • Kanagawa
    • Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3, Kanagawa, Japan, 213-8507
      • Teikyo University Hospital, Mizonokuchi
    • Sagamihara,Asamizodai,2-1-1, Kanagawa, Japan, 228-8520
      • Kitasato University East Hospital
    • Sagamihara,Kitasato,1-15-1, Kanagawa, Japan, 228-8555
      • Kitasato University School of Medichine
    • Yokohama,Tsuzuki-ku,Chigasakichuo,35-1, Kanagawa, Japan, 224-8503
      • Showa University Northern Yokohama Hospital
  • Kyoto
    • Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1, Kyoto, Japan, 612-8555
      • National Hospital Organization Kyoto Medical Center
  • Nagano
    • Nagano,Tomitake,1333-1, Nagano, Japan, 381-8551
      • Nagano Municipal Hospital
  • Oita
    • Yufu city,Hasama-machi, 1-1, Oita, Japan, 879-5593
      • Oita University Faculty of Medicine
  • Osaka
    • Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan, 534-0021
      • Osaka City General Hospital
    • Suita,Yamada-oka,2-2, Osaka, Japan, 565-0871
      • Osaka University Graduate School of Medicine
    • Takatsuki,Daigakucho,2-7, Osaka, Japan, 569-0801
      • Osaka Medical College
  • Saitama
    • Saitama,Omiya-ku,Amanuma-cho,1-847, Saitama, Japan, 330-8503
      • Omiya Medical Center, Jichi Medical School
  • Shizuoka
    • Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan, 411-8777
      • Sizuoka Cancer Center
  • Tokyo
    • Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan, 113-8519
      • Tokyo Medical and Dental University Hospital
    • Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
    • Meguro-ku,Ohashi,2-17-6, Tokyo, Japan, 153-0044
      • Toho University Ohashi Hospital
    • Minato-ku,Toranomon,2-2-2, Tokyo, Japan, 105-8470
      • Toranomon Hospital
    • Mitaka,Shinkawa,6-20-2, Tokyo, Japan, 181-8611
      • Kyorin University School of Medicine
    • Shinjuku-ku,Shinanomachi,35, Tokyo, Japan, 160-8582
      • Keio University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1; Procedure/Surgery: open colectomy	Procedure: open colectomy; Procedure/Surgery: open colectomy
EXPERIMENTAL: 2; Procedure/Surgery: laparoscopic colectomy	Procedure: laparoscopic colectomy; Procedure/Surgery: laparoscopic colectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	During the study conduct

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Haruhiko Fukuda
• Collaborators: Ministry of Health, Labour and Welfare, Japan
• Investigators: Study Chair: Seigo Kitano, MD, PhD,FACS, Oita University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: September 5, 2005
• First Submitted That Met QC Criteria: September 5, 2005
• First Posted (ESTIMATE): September 7, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): September 22, 2016
• Last Update Submitted That Met QC Criteria: September 20, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: colorectal cancer; randomized controlled trial; laparoscopic surgery; oncological outcome
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: JCOG0404; C000000105