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Three-Year Follow-Up of the Randomized Trial Comparing Open Versus Laparoscopic Surgery for Primary Tumor Resection in Patients With Non-Curable Stage IV Colon Cancer (JCOG1107)

In brief

Laparoscopic surgery matches open surgery for three-year survival in unresectable stage IV colon cancer

In a randomized trial of 195 patients with non-curable stage IV colon cancer, three-year overall survival was 31.5% after open resection and 28.5% after laparoscopic resection, with progression-free survival also similar (5.3% vs 3.0%). Late severe complications were rare in both groups. The results support laparoscopy as an acceptable alternative to open surgery, though chemotherapy was given without molecular stratification.

Journal
Diseases of the colon and rectum (Q2)
Published
16 July 2026
Study design
Randomized controlled trial
Evidence level
Level 1, High (CEBM 1b)
Authors
Akio Shiomi, Tomonori Akagi, Riku Kajikawa, Hiroshi Katayama, Junki Mizusawa, Takumi Hasegawa, et al.
PMID
42461618
DOI
10.1097/DCR.0000000000004373

Why clinicians should know about it

Abstract

BACKGROUND: JCOG1107 (UMIN-CTR, number UMIN000009715) was a non-inferiority phase III trial comparing laparoscopic and open surgery for symptomatic, non-curable stage IV colon cancer. The primary analysis confirmed the non-inferiority of laparoscopic surgery in terms of progression-free survival. OBJECTIVE: To compare long-term outcomes of laparoscopic and open surgery for stage IV colon cancer. DESIGN: Multicenter, open-label, randomized, controlled phase III trial. SETTING: Forty-two Japanese institutions. PATIENTS: Participants were considered eligible if they had pathologically confirmed adenocarcinoma or adenosquamous carcinoma with a primary tumor between the cecum and rectosigmoid, presenting with stenosis and/or bleeding, and one to three non-curable factors. The required sample size was 194 to ensure 70% power, a one-sided alpha of 5%, and a non-inferiority hazard ratio margin of 1.38. INTERVENTIONS: Patients were randomized to receive either open or laparoscopic primary tumor resection, followed by modified FOLFOX6 plus bevacizumab or capecitabine plus oxaliplatin with bevacizumab. MAIN OUTCOME MEASURES: The primary endpoint was progression-free survival. RESULTS: A total of 195 patients were randomized, including 95 open and 100 laparoscopic surgeries. Postoperative chemotherapy was given to 82 and 86 patients, respectively. The median follow-up period for all randomized patients was 24.4 months. Grade ≥3 late complications occurred in one open (1.1%) and two laparoscopic (2.0%) patients. Three-year progression-free survival was 5.3% (95% confidence interval: 2.0-11.0) for open surgery and 3.0% (0.8-7.8) for laparoscopic surgery (hazard ratio: 1.028; 95% confidence interval: 0.772-1.370; p for non-inferiority = 0.02). The three-year overall survival was 31.5% (22.5-41.0) and 28.5% (20.0-37.6) (hazard ratio: 1.048; 95% confidence interval: 0.780-1.410), respectively. LIMITATIONS: Chemotherapy was administered without knowledge of microsatellite instability or RAS/BRAF mutation status. CONCLUSION: Laparoscopic surgery is non-inferior to open surgery for non-curable stage IV colon cancer and should be considered an acceptable surgical option. See Video Abstract.

Abstract as published, via PubMed.

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For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.