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A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00147134
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : September 22, 2016
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Haruhiko Fukuda, Japan Clinical Oncology Group

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: open colectomy Procedure: laparoscopic colectomy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer(JCOG 0404,CRC Surg-LAP/OPEN)
Study Start Date : November 2004
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Overall survival [ Time Frame: During the study conduct ]

Secondary Outcome Measures :
  1. Relapse-free survival [ Time Frame: During the study conduct ]
  2. Short-term clinical outcomes [ Time Frame: time to 1st discharge after operation ]
  3. Adverse events [ Time Frame: During the study conduct ]
  4. The proportion of conversion from LAP to OPEN [ Time Frame: operation day ]
  5. The proportion of completion of LAP [ Time Frame: operation day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00147134

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group Identifier: NCT00147134     History of Changes
Other Study ID Numbers: JCOG0404
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016
Keywords provided by Haruhiko Fukuda, Japan Clinical Oncology Group:
colorectal cancer
laparoscopic surgery
randomized controlled trial
oncological outcome
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases