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A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
open colectomy
laparoscopic colectomy
Sponsored by
Haruhiko Fukuda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer, laparoscopic surgery, randomized controlled trial, oncological outcome

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically proven colorectal carcinoma Tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon T3 or deeper lesion without involvement of other organs Without multiple lesion other than carcinoma in situ Cancer classified as N0-2 and M0, according to the TNM classification system Tumor size < 8 cm No bowel obstruction Age 20 < and > 75 years Sufficient organ function No history of gastrointestinal surgery No history of chemotherapy or radiotherapy Provided written informed consent Exclusion Criteria: Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ Severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease Pregnant or lactating women Severe mental disease Continuous systemic steroid therapy

Sites / Locations

  • Fujita Health University
  • National Cancer Center Hospital East
  • Toho University Sakura Hospital
  • Jyuntendo Urayasu Hospital
  • National Hospital Organization Shikoku Cancer Center
  • Kurume University School of Medicine
  • Hiroshima University, School of Medicine
  • Ishikawa Prefectual Central Hospital
  • Teikyo University Hospital, Mizonokuchi
  • Kitasato University East Hospital
  • Kitasato University School of Medichine
  • Showa University Northern Yokohama Hospital
  • National Hospital Organization Kyoto Medical Center
  • Nagano Municipal Hospital
  • Oita University Faculty of Medicine
  • Osaka City General Hospital
  • Osaka University Graduate School of Medicine
  • Osaka Medical College
  • Omiya Medical Center, Jichi Medical School
  • Sizuoka Cancer Center
  • Tokyo Medical and Dental University Hospital
  • National Cancer Center Hospital
  • Toho University Ohashi Hospital
  • Toranomon Hospital
  • Kyorin University School of Medicine
  • Keio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Procedure/Surgery: open colectomy

Procedure/Surgery: laparoscopic colectomy

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Relapse-free survival
Short-term clinical outcomes
Adverse events
The proportion of conversion from LAP to OPEN
The proportion of completion of LAP

Full Information

First Posted
September 5, 2005
Last Updated
September 20, 2016
Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00147134
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, laparoscopic surgery, randomized controlled trial, oncological outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1050 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Procedure/Surgery: open colectomy
Arm Title
2
Arm Type
Experimental
Arm Description
Procedure/Surgery: laparoscopic colectomy
Intervention Type
Procedure
Intervention Name(s)
open colectomy
Intervention Description
Procedure/Surgery: open colectomy
Intervention Type
Procedure
Intervention Name(s)
laparoscopic colectomy
Intervention Description
Procedure/Surgery: laparoscopic colectomy
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
During the study conduct
Secondary Outcome Measure Information:
Title
Relapse-free survival
Time Frame
During the study conduct
Title
Short-term clinical outcomes
Time Frame
time to 1st discharge after operation
Title
Adverse events
Time Frame
During the study conduct
Title
The proportion of conversion from LAP to OPEN
Time Frame
operation day
Title
The proportion of completion of LAP
Time Frame
operation day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven colorectal carcinoma Tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon T3 or deeper lesion without involvement of other organs Without multiple lesion other than carcinoma in situ Cancer classified as N0-2 and M0, according to the TNM classification system Tumor size < 8 cm No bowel obstruction Age 20 < and > 75 years Sufficient organ function No history of gastrointestinal surgery No history of chemotherapy or radiotherapy Provided written informed consent Exclusion Criteria: Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ Severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease Pregnant or lactating women Severe mental disease Continuous systemic steroid therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seigo Kitano, MD, PhD,FACS
Organizational Affiliation
Oita University
Official's Role
Study Chair
Facility Information:
Facility Name
Fujita Health University
City
Toyoake,Kutsukake-cho,Dengakugakubo,1-98
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa,Kashiwanoha,6-5-1
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Toho University Sakura Hospital
City
Sakura,Shimoshidu,564-1
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Jyuntendo Urayasu Hospital
City
Urayasu,Tomioka,2-1-1
State/Province
Chiba
ZIP/Postal Code
279-0021
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama,Horinouchi,13
State/Province
Ehime
ZIP/Postal Code
790-0007
Country
Japan
Facility Name
Kurume University School of Medicine
City
Kurume,Asahi-machi,67
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Hiroshima University, School of Medicine
City
Hiroshima,Minami-ku,Kasumi,1-2-3
State/Province
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Ishikawa Prefectual Central Hospital
City
Kanazawa,Kuratsuki-Higashi,2-1
State/Province
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
Facility Name
Teikyo University Hospital, Mizonokuchi
City
Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3
State/Province
Kanagawa
ZIP/Postal Code
213-8507
Country
Japan
Facility Name
Kitasato University East Hospital
City
Sagamihara,Asamizodai,2-1-1
State/Province
Kanagawa
ZIP/Postal Code
228-8520
Country
Japan
Facility Name
Kitasato University School of Medichine
City
Sagamihara,Kitasato,1-15-1
State/Province
Kanagawa
ZIP/Postal Code
228-8555
Country
Japan
Facility Name
Showa University Northern Yokohama Hospital
City
Yokohama,Tsuzuki-ku,Chigasakichuo,35-1
State/Province
Kanagawa
ZIP/Postal Code
224-8503
Country
Japan
Facility Name
National Hospital Organization Kyoto Medical Center
City
Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1
State/Province
Kyoto
ZIP/Postal Code
612-8555
Country
Japan
Facility Name
Nagano Municipal Hospital
City
Nagano,Tomitake,1333-1
State/Province
Nagano
ZIP/Postal Code
381-8551
Country
Japan
Facility Name
Oita University Faculty of Medicine
City
Yufu city,Hasama-machi, 1-1
State/Province
Oita
ZIP/Postal Code
879-5593
Country
Japan
Facility Name
Osaka City General Hospital
City
Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22
State/Province
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Osaka University Graduate School of Medicine
City
Suita,Yamada-oka,2-2
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Osaka Medical College
City
Takatsuki,Daigakucho,2-7
State/Province
Osaka
ZIP/Postal Code
569-0801
Country
Japan
Facility Name
Omiya Medical Center, Jichi Medical School
City
Saitama,Omiya-ku,Amanuma-cho,1-847
State/Province
Saitama
ZIP/Postal Code
330-8503
Country
Japan
Facility Name
Sizuoka Cancer Center
City
Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyo-ku,Yushima,1-5-45
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku,Tsukiji,5-1-1
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Toho University Ohashi Hospital
City
Meguro-ku,Ohashi,2-17-6
State/Province
Tokyo
ZIP/Postal Code
153-0044
Country
Japan
Facility Name
Toranomon Hospital
City
Minato-ku,Toranomon,2-2-2
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Kyorin University School of Medicine
City
Mitaka,Shinkawa,6-20-2
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku,Shinanomachi,35
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
34755012
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.
Results Reference
derived
PubMed Identifier
31131360
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.
Results Reference
derived
PubMed Identifier
31131359
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.
Results Reference
derived
PubMed Identifier
28404155
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.
Results Reference
derived
PubMed Identifier
24509190
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.
Results Reference
derived
Links:
URL
http://www.jcog.jp/
Description
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A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

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