About this trial
The study was designed as single-country, multi-center, open-labelled, randomized (1:1), phase II trial.
238 patients with medically and technically operable advanced gastric adenocarcinoma in middle or distal 1/3 of stomach are enrolled and randomly assigned to laparoscopic gastrectomy group and open gastrectomy group. 4 cycles of mFLOT chemotherapy will be conducted before and after gastrectomy.
The primary objective of this study is comparison of D2 lymph node dissection compliance rate between open surgery group and laparoscopic surgery group after neoadjuvant chemotherapy.
Eligibility criteria
Qualifiers
Patients who voluntarily expressed their consent to participate in this trial by signing a written 'Subject Consent Form.'
Patients whose gastric adenocarcinoma located in the middle or lower part of the stomach is histologically confirmed and deemed possible to perform a radical distal gastrectomy surgery.
Patients who come under T2/N(+)M0, T3~4a/N(- or +) M0 according to the 8th edition of the TNM classification.
Disqualifiers
Methodologies
Patients less than 20 years old or older than 80 years old
Eastern Cooperative Oncology Group(ECOG) ≥ 2
Patients with a surgery experience due to a neoplasm in the stomach.
Trial design
Treatments tested in this trial
- Laparoscopic versus open distal gastrectomy