A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147134
• Other study ID #: JCOG0404
• Secondary ID: C000000105
• Status: Completed
• Phase: Phase 3
• First received: September 5, 2005
• Last updated: September 20, 2016
• Start date: November 2004
• Est. completion date: March 2014

Study information

• Verified date: September 2016
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1050
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• open colectomy
Procedure/Surgery: open colectomy
• laparoscopic colectomy
Procedure/Surgery: laparoscopic colectomy

Locations

Country	Name	City	State
Japan	Tokyo Medical and Dental University Hospital	Bunkyo-ku,Yushima,1-5-45	Tokyo
Japan	National Cancer Center Hospital	Chuo-ku,Tsukiji,5-1-1	Tokyo
Japan	Hiroshima University, School of Medicine	Hiroshima,Minami-ku,Kasumi,1-2-3	Hiroshima
Japan	Ishikawa Prefectual Central Hospital	Kanazawa,Kuratsuki-Higashi,2-1	Ishikawa
Japan	National Cancer Center Hospital East	Kashiwa,Kashiwanoha,6-5-1	Chiba
Japan	Teikyo University Hospital, Mizonokuchi	Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3	Kanagawa
Japan	Kurume University School of Medicine	Kurume,Asahi-machi,67	Fukuoka
Japan	National Hospital Organization Kyoto Medical Center	Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1	Kyoto
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama,Horinouchi,13	Ehime
Japan	Toho University Ohashi Hospital	Meguro-ku,Ohashi,2-17-6	Tokyo
Japan	Toranomon Hospital	Minato-ku,Toranomon,2-2-2	Tokyo
Japan	Kyorin University School of Medicine	Mitaka,Shinkawa,6-20-2	Tokyo
Japan	Nagano Municipal Hospital	Nagano,Tomitake,1333-1	Nagano
Japan	Osaka City General Hospital	Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22	Osaka
Japan	Kitasato University East Hospital	Sagamihara,Asamizodai,2-1-1	Kanagawa
Japan	Kitasato University School of Medichine	Sagamihara,Kitasato,1-15-1	Kanagawa
Japan	Omiya Medical Center, Jichi Medical School	Saitama,Omiya-ku,Amanuma-cho,1-847	Saitama
Japan	Toho University Sakura Hospital	Sakura,Shimoshidu,564-1	Chiba
Japan	Keio University Hospital	Shinjuku-ku,Shinanomachi,35	Tokyo
Japan	Osaka University Graduate School of Medicine	Suita,Yamada-oka,2-2	Osaka
Japan	Sizuoka Cancer Center	Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007	Shizuoka
Japan	Osaka Medical College	Takatsuki,Daigakucho,2-7	Osaka
Japan	Fujita Health University	Toyoake,Kutsukake-cho,Dengakugakubo,1-98	Aichi
Japan	Jyuntendo Urayasu Hospital	Urayasu,Tomioka,2-1-1	Chiba
Japan	Showa University Northern Yokohama Hospital	Yokohama,Tsuzuki-ku,Chigasakichuo,35-1	Kanagawa
Japan	Oita University Faculty of Medicine	Yufu city,Hasama-machi, 1-1	Oita

Sponsors (2)

Lead Sponsor	Collaborator
Haruhiko Fukuda	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		During the study conduct	No
Secondary	Relapse-free survival		During the study conduct	No
Secondary	Short-term clinical outcomes		time to 1st discharge after operation	Yes
Secondary	Adverse events		During the study conduct	Yes
Secondary	The proportion of conversion from LAP to OPEN		operation day	Yes
Secondary	The proportion of completion of LAP		operation day	No

External Links

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