Clinical trial NCT00147134: A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer
Official title: Randomized Controlled Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer（JCOG 0404,CRC Surg-LAP/OPEN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: colorectal cancer
laparoscopic surgery
randomized controlled trial
oncological outcome
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-09-07
Enrollment: 1050
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: During the study conduct
Secondary outcomes:
measure: Relapse-free survival
timeFrame: During the study conduct
measure: Short-term clinical outcomes
timeFrame: time to 1st discharge after operation
measure: Adverse events
timeFrame: During the study conduct
measure: The proportion of conversion from LAP to OPEN
timeFrame: operation day
measure: The proportion of completion of LAP
timeFrame: operation day
Other outcomes:
Locations:
city: Toyoake,Kutsukake-cho,Dengakugakubo,1-98
country: Japan
facility: Fujita Health University
state: Aichi
city: Kashiwa,Kashiwanoha,6-5-1
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Sakura,Shimoshidu,564-1
country: Japan
facility: Toho University Sakura Hospital
state: Chiba
city: Urayasu,Tomioka,2-1-1
country: Japan
facility: Jyuntendo Urayasu Hospital
state: Chiba
city: Matsuyama,Horinouchi,13
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Kurume,Asahi-machi,67
country: Japan
facility: Kurume University School of Medicine
state: Fukuoka
city: Hiroshima,Minami-ku,Kasumi,1-2-3
country: Japan
facility: Hiroshima University, School of Medicine
state: Hiroshima
city: Kanazawa,Kuratsuki-Higashi,2-1
country: Japan
facility: Ishikawa Prefectual Central Hospital
state: Ishikawa
city: Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3
country: Japan
facility: Teikyo University Hospital, Mizonokuchi
state: Kanagawa
city: Sagamihara,Asamizodai,2-1-1
country: Japan
facility: Kitasato University East Hospital
state: Kanagawa
city: Sagamihara,Kitasato,1-15-1
country: Japan
facility: Kitasato University School of Medichine
state: Kanagawa
city: Yokohama,Tsuzuki-ku,Chigasakichuo,35-1
country: Japan
facility: Showa University Northern Yokohama Hospital
state: Kanagawa
city: Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1
country: Japan
facility: National Hospital Organization Kyoto Medical Center
state: Kyoto
city: Nagano,Tomitake,1333-1
country: Japan
facility: Nagano Municipal Hospital
state: Nagano
city: Yufu city,Hasama-machi, 1-1
country: Japan
facility: Oita University Faculty of Medicine
state: Oita
city: Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22
country: Japan
facility: Osaka City General Hospital
state: Osaka
city: Suita,Yamada-oka,2-2
country: Japan
facility: Osaka University Graduate School of Medicine
state: Osaka
city: Takatsuki,Daigakucho,2-7
country: Japan
facility: Osaka Medical College
state: Osaka
city: Saitama,Omiya-ku,Amanuma-cho,1-847
country: Japan
facility: Omiya Medical Center, Jichi Medical School
state: Saitama
city: Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007
country: Japan
facility: Sizuoka Cancer Center
state: Shizuoka
city: Bunkyo-ku,Yushima,1-5-45
country: Japan
facility: Tokyo Medical and Dental University Hospital
state: Tokyo
city: Chuo-ku,Tsukiji,5-1-1
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Meguro-ku,Ohashi,2-17-6
country: Japan
facility: Toho University Ohashi Hospital
state: Tokyo
city: Minato-ku,Toranomon,2-2-2
country: Japan
facility: Toranomon Hospital
state: Tokyo
city: Mitaka,Shinkawa,6-20-2
country: Japan
facility: Kyorin University School of Medicine
state: Tokyo
city: Shinjuku-ku,Shinanomachi,35
country: Japan
facility: Keio University Hospital
state: Tokyo
Study officials:
affiliation: Oita University
name: Seigo Kitano, MD, PhD,FACS
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.