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JCOG0404

Laparoscopic versus open D3 dissection for stage II or III colon cancer (JCOG0404)

Phase 3N = 1,057NCT00147134

Population
Patients aged 20-75 years with histologically proven colon cancer in the caecum or ascending, sigmoid or rectosigmoid colon; T3 or deeper without involvement of other organs, N0-2, M0, tumour size 8 cm or smaller. 1057 randomised between 1 October 2004 and 27 March 2009.
Design
Open-label, multi-institutional, randomised, two-arm phase 3 trial in 30 hospitals in Japan (1:1 randomisation, minimisation with biased-coin assignment by tumour location and institution) of open versus laparoscopic D3 resection, by accredited surgeons. Primary endpoint overall survival, analysed by intention to treat; non-inferiority margin for the hazard ratio 1.366. Also registered UMIN C000000105.
Primary endpoint
OS
Arms
  • Open D3 resection (control, n = 528): Open D3 dissection
  • Laparoscopic D3 resection (experimental, n = 529): Laparoscopic D3 dissection
People
Kitano S, Japan Clinical Oncology Group (JCOG)
OSHR 1.06Δ 60-month OS+1.4 points
Show the numbers
Results reported for JCOG0404
EndpointAnalysisLaparoscopic D3 resectionOpen D3 resectionEffect
OSITT (as stated in the abstract); stage II or III colon cancer, 1057 randomisedprimaryKitano 201791.8% at 5 y (89.1–93.8%)90.4% at 5 y (87.5–92.6%)HR 1.06P=0.073The hazard ratio is published with a 90% confidence interval of 0.79 to 1.41; the P value (0.073) is for non-inferiority against the margin of 1.366. The authors state that laparoscopic D3 surgery was not non-inferior to open surgery for overall survival.
Results reported for JCOG0404
EndpointAnalysisLaparoscopic D3 resectionOpen D3 resectionEffect
OSITT (as stated in the abstract); stage II or III colon cancer, 1057 randomisedprimaryKitano 201791.8% at 5 y (89.1–93.8%)90.4% at 5 y (87.5–92.6%)HR 1.06P=0.073The hazard ratio is published with a 90% confidence interval of 0.79 to 1.41; the P value (0.073) is for non-inferiority against the margin of 1.366. The authors state that laparoscopic D3 surgery was not non-inferior to open surgery for overall survival.
Primary publication: Kitano S, Inomata M, Mizusawa J, Katayama H, Watanabe M, Yamamoto S, et al. 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;2(4):261-268. PubMedDOI

Appears in

Sources

  1. Kitano S, Inomata M, Mizusawa J, Katayama H, Watanabe M, Yamamoto S, et al. 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;2(4):261-268.

    PubMedDOI