KLASS 06



ClinicalTrials.gov Identifier: NCT03385018

FULL NAME Multicenter Randomized Controlled Trial for Application of Laparoscopic Total Gastrectomy with Lymph Node Dissection for Gastric Cancer (KLASS-06)
STUDY DESIGN Prospective, Multi-center, Interventional (Clinical Trial), Randomized controlled study
Estimated Enrollment: 772 participants
Intervention Model: Parallel Assignment
Intervention Model Description: 2-arm randomized controlled study

- Experimental: Laparoscopic group (Laparoscopic radical total gastrectomy with D2 (or D2-#10) lymph node dissection)
- Active Comparator: Open group (Open radical total gastrectomy with D2 (or D2-#10) lymph node dissection)

Primary endpoint: 3 year relapse-free survival [Time Frame: 3 years after surgery] Eligibility Criteria
Inclusion Criteria:
  • Patients who are over 20 and below 80 years old
  • Patients who have performance status of ECOG 0 or 1
  • Patients with American Society of Anesthesiology score of class I to III
  • Patients who are diagnosed with gastric adenocarcinoma not involving Z-line by endoscopy with biopsy
  • Patients with tumors which can be curatively resected by total gastrectomy with lymph node dissection based on preoperative study
  • Patients who have primary gastric carcinoma invaded into over muscle propria, and not into adjacent organ in preoperative studies (cT2 ~ cT4a)
  • Patients who have no metastasis to lymph nodes or limited metastasis to perigastric lymph node metastasis in preoperative studies (cN0 ~ cN2)
  • Patients who agree with participating in the clinical study with informed consents
  • Patients who can be followed for at least 3 years after study enrollment
Exclusion Criteria:
  • Patients who have possibility of distant metastasis in preoperative studies
  • Patients who have history of gastric resection with any cause
  • Patients who have complications (bleeding or obstruction) of gastric cancer
  • Patients who are treated by chemo(radio)therapy or endoscopic submucosal dissection for gastric cancer
  • Patients who are diagnosed and treated with other malignancies within 5 years
  • Vulnerable patients
  • Patients who participating or participated in other clinical trial within 6 months
Principle Investigator Woo Jin Hyung(Yonsei University College of Medicine)
E-mail: wjhyung@yuhs.ac
Chronology 2018. 4 Study Start
PUBLICATED ARTICLES Study is ongoing