KLASS 06
KLASS trial > 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)
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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
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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
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