Laparoscopic vs. Open Distal Gastrectomy After Neoadjuvant Chemotherapy

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

The effect of neoadjuvant chemotherapy on locally advanced gastric cancer was confirmed from a prospective clinical trial. Oncologic safety and excellence of the laparoscopic gastrectomy surgery was recently established for locally advanced gastric cancer. However, neither technical nor oncologic stability was established for laparoscopic gastrectomy surgery after neoadjuvant chemotherapy. Anticipated benefits from laparoscopic gastrectomy surgery after neoadjuvant chemotherapy are as follows: 1) Reduced postoperative complications; 2) Reduced intra- or postoperative transfusion and patient's pain after surgery; 3) Enhance postoperative recovery (shortened hospitalization duration); 4) Facilitate completion rate of adjuvant chemotherapy. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04658589
Study type	Interventional
Source	Chonnam National University Hospital
Contact	Young-Kyu Park, MD
Phone	+82-10-7173-1196
Email	parkyk@jnu.ac.kr
Status	Not yet recruiting
Phase	N/A
Start date	January 2021
Completion date	December 2026

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.