Laparoscopic vs. Open Distal Gastrectomy After Neoadjuvant Chemotherapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorChonnam National University Hospital

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

Treatment groups

238 Participants
are divided into 2 treatment groups

Locations

This trial has no locations