This trial is active, not recruiting.

Condition colorectal cancer
Treatments open colectomy, laparoscopic colectomy
Phase phase 3
Sponsor Japan Clinical Oncology Group
Collaborator Ministry of Health, Labour and Welfare, Japan
Start date November 2004
End date March 2014
Trial size 1050 participants
Trial identifier NCT00147134, C000000105, JCOG0404


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Procedure/Surgery: open colectomy
open colectomy
Procedure/Surgery: open colectomy
Procedure/Surgery: laparoscopic colectomy
laparoscopic colectomy
Procedure/Surgery: laparoscopic colectomy

Primary Outcomes

Overall survival
time frame: During the study conduct

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

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

Additional Information

Official title Randomized Controlled Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer(JCOG 0404,CRC Surg-LAP/OPEN)
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2009.
Information provided to ClinicalTrials.gov by Japan Clinical Oncology Group.