A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

• ClinicalTrials.gov Identifier: NCT00147134
• Recruitment Status: Completed
• First Posted: September 7, 2005
• Last Update Posted: September 22, 2016
• Sponsor: Haruhiko Fukuda
• Collaborator: Ministry of Health, Labour and Welfare, Japan
• Information provided by (Responsible Party): Haruhiko Fukuda, Japan Clinical Oncology Group

Tracking Information

• First Submitted Date: September 5, 2005
• First Posted Date: September 7, 2005
• Last Update Posted Date: September 22, 2016
• Study Start Date: November 2004
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 21, 2008): Overall survival [ Time Frame: During the study conduct ]
• Original Primary Outcome Measures (submitted: September 5, 2005): overall survival

Current Secondary Outcome Measures (submitted: October 21, 2008)

• Relapse-free survival [ Time Frame: During the study conduct ]
• Short-term clinical outcomes [ Time Frame: time to 1st discharge after operation ]
• Adverse events [ Time Frame: During the study conduct ]
• The proportion of conversion from LAP to OPEN [ Time Frame: operation day ]
• The proportion of completion of LAP [ Time Frame: operation day ]

Original Secondary Outcome Measures (submitted: September 5, 2005)

• relapse-free survival
• short-term clinical outcomes
• adverse events
• the proportion of conversion from LAP to OPEN
• the proportion of completion of LAP

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Colorectal Cancer

Intervention

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

Study Arms

• Active Comparator: 1
  Procedure/Surgery: open colectomy
  Intervention: Procedure: open colectomy
• Experimental: 2
  Procedure/Surgery: laparoscopic colectomy
  Intervention: Procedure: laparoscopic colectomy

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 2, 2009): 1050
• Original Enrollment (submitted: September 5, 2005): 818
• Actual Study Completion Date: March 2014
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00147134
• Other Study ID Numbers: JCOG0404; C000000105
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Haruhiko Fukuda, Japan Clinical Oncology Group
• Original Responsible Party: Not Provided
• Current Study Sponsor: Haruhiko Fukuda
• Original Study Sponsor: Japan Clinical Oncology Group
• Collaborators: Ministry of Health, Labour and Welfare, Japan

Investigators

• Study Chair: Seigo Kitano, MD, PhD,FACS; Oita University

• PRS Account: Japan Clinical Oncology Group
• Verification Date: September 2016