A phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric cancer (JCOG0912): Analysis of the safety and short-term clinical outcomes.

4020 Background: The number of patients undergoing laparoscopy-assisted distal gastrectomy (LADG) has been increasing worldwide. Several retrospective studies have demonstrated equivalent survival after LADG compared to open distal gastrectomy (ODG). However, no confirmatory randomized controlled trials has been published in a peer review journal to evaluate the efficacy of LADG compared with ODG, ensuring strict surgical skill and quality control of surgery. We conducted phase III study to confirm that LADG is not inferior to ODG in efficacy. Methods: Eligibility criteria included histologically proven adenocarcinoma in the middle or lower third of the stomach; clinical stage I tumor (T1N0, T1N1, T2(MP)N0). Patients were preoperatively randomized to ODG or LADG. LADG was performed by accredited surgeon. The extent of nodal dissection was decided according to Japanese gastric cancer treatment guidelines. The primary endpoint is relapse-free survival (RFS) and the secondary endpoints are overall survival (OS), short-term clinical outcomes, and postoperative quality of life. Planned sample size was 920 patients in total, which was determined with at least 80% power, a one-sided alpha of 5%, and a non-inferiority margin for a hazard ratio of 1.54. Before the 1st interim analysis, the primary endpoint was amended from OS to RFS in 2015 because the surrogacy of RFS for OS was demonstrated and the predicted number of events for OS was smaller than expected. Results: A total of 921 patients were randomized (ODG 459, LADG 462) between Mar. 2010 and Nov. 2013. Among 921 patients, 912 patients (99%) underwent assigned surgery. Conversion to ODG was needed for 16 patients (3.5%) in LADG arm mainly due to advanced disease. 5-year RFS was 94.0% (95% CI: 91.4-95.9%) in ODG and 95.1% (92.7-96.8%) in LADG. LADG was non-inferior to ODG for RFS. (HR: 0.84 [90% CI: 0.56-1.27 ( < 1.54)], p for non-inferiority = 0.008). 5-year OS was 95.2% (92.7-96.8) in ODG and 97.0% (94.9-98.2) in LADG (HR: 0.83 [95% CI: 0.49-1.40]). Conclusions: The non-inferiority of LADG to ODG in RFS was confirmed. LADG has been established as one of the standard treatments for clinical stage I gastric cancer. Clinical trial information: UMIN000003319.

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Long-term survival results of laparoscopy-assisted distal gastrectomy with suprapancreatic nodal dissection for clinical stage I gastric cancer: A multicenter phase II trial (JCOG 0703).

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.113 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. 113-113 ◽

Cited By ~ 1

Author(s):

Mikihito Nakamori ◽

Hitoshi Katai ◽

Junki Mizusawa ◽

Kenichi Nakamura ◽

Naoki Hiki ◽

...

Keyword(s):

Gastric Cancer ◽

Cancer Patients ◽

Distal Gastrectomy ◽

Clinical Stage ◽

Stage I ◽

Phase Iii ◽

Term Outcome ◽

Nodal Dissection ◽

Gastric Cancer Patients

113 Background: Laparoscopic gastrectomy has been a common tool for gastric cancer patients in eastern Asian countries. A large-scale prospective study with a sample size sufficient to investigate the benefit of laparoscopy-assisted distal gastrectomy (LADG) has never been reported. We conducted a multi-center phase II trial (JCOG0703) to evaluate the safety of LADG with nodal dissection for clinical stage I gastric cancer patients. A short-term outcome including postoperative complications of LADG as a result of this study was already reported and a following multi-center phase III trials (JCOG0912) to confirm the non-inferiority of LADG compared with open gastrectomy in terms of overall survival (OS) was already started. Long-term outcomes as the secondary endpoints of this study are reported here after 5-year follow up period. Methods: The subjects of this study comprised patients with clinical stage I gastric cancer that were able to undergo a distal gastrectomy. LADG with D1 plus suprapancreatic lymph node dissection was performed by credentialed gastric surgeons who experienced >=30 LADG and >=30 open gasterctomy. The primary endpoint was the proportion of patients who developed either anastomotic leakage or a pancreatic fistula. The secondary endpoints included surgical morbidity, short-term clinical outcome, OS, and relapse free survival (RFS). Results: Between November 2007 and September 2008, 176 eligible patients were enrolled. 140/23/9/4 patients had pStage IA/IB/II/IIIA disease respectively. No patients had recurrence. 3 patients died without recurrence. 5-year OS was 98.2% (95%CI, 94.7% to 99.4%). 5-year RFS was 98.2% (95%CI, 94.4% to 99.4%). Conclusions: The long-term outcome of LADG for Stage I gastric cancer patients seem comparable to those of open procedures. However, this result should be confirmed by a randomized control trial. We have just finished an accrual of 921 patients for a multi-center phase III trial (JCOG0912) to confirm the non-inferiority of LADG compared with open gastrectomy in terms of OS. Clinical trial information: UMIN000000874.

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