Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Japan Clinical Oncology Group.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00147134
First received: September 5, 2005
Last updated: August 2, 2009
Last verified: August 2009
  Purpose

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


Condition Intervention Phase
Colorectal Cancer
Procedure: open colectomy
Procedure: laparoscopic colectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • Overall survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relapse-free survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • Short-term clinical outcomes [ Time Frame: time to 1st discharge after operation ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: During the study conduct ] [ Designated as safety issue: Yes ]
  • The proportion of conversion from LAP to OPEN [ Time Frame: operation day ] [ Designated as safety issue: Yes ]
  • The proportion of completion of LAP [ Time Frame: operation day ] [ Designated as safety issue: No ]

Estimated Enrollment: 1050
Study Start Date: November 2004
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147134

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

Additional Information:
No publications provided by Japan Clinical Oncology Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seigo Kitano, MD, PhD,FACS, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00147134     History of Changes
Other Study ID Numbers: JCOG0404, C000000105
Study First Received: September 5, 2005
Last Updated: August 2, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:
colorectal cancer
laparoscopic surgery
randomized controlled trial
oncological outcome

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 25, 2014