Clinical trial NCT03385018: Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)
Official title: Multicenter Randomized Controlled Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 772
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm randomized controlled study
Primary purpose: TREATMENT

Brief summary: Although Laparoscopic gastrectomy for both early and locally advanced gastric cancer has gained popularity, the use of laparoscopic total gastrectomy for proximal advanced gastric cancer is still limited to some experienced surgeons, because of its technical difficulties in D2 lymph node dissection and anastomoses.

Some retrospective and cohort studies regarding laparoscopic total gastrectomy with lymph node dissection suggested the likelihood of application of laparoscopic surgery for proximal gastric cancer. However, there has been no randomized clinical trial comparing results of laparoscopic total gastrectomy with D2 lymph node dissection with open conventional surgery.

Therefore, we aimed to verify the efficacy of laparoscopic total gastrectomy with D2(D2-10) lymph node dissection, technical and oncologic safety compared with open surgery via multicenter randomized clinical trial.


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

Primary outcomes:
measure: 3 year relapse-free survival
timeFrame: 3 years after surgery
Secondary outcomes:
measure: 3 year overall survival rate
timeFrame: 3 years after surgery
measure: 5 year relapse-free and overall survival
timeFrame: 5 years after surgery
measure: Morbidity (early period)
timeFrame: from Operation day until POD 21
measure: Morbidity (late period)
timeFrame: from POD (Post-Operative Day) 22 until 5 years after surgery
measure: Mortality
timeFrame: at POD 30
measure: Mortality
timeFrame: at POD 90
measure: Quality of life(EORTC QLQ-C30)
timeFrame: at POD 21
measure: Quality of life(EORTC QLC STO22)
timeFrame: at POD 21
measure: Quality of life(EORTC QLQ-C30)
timeFrame: 3 months after surgery
measure: Quality of life(EORTC QLC STO22)
timeFrame: 3 months after surgery
measure: Quality of life(EORTC QLQ-C30)
timeFrame: 12 months after surgery
measure: Quality of life(EORTC QLC STO22)
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
Study officials:
References: