Efficacy of Laparoscopic Subtotal Gastrectomy With D2 Lymph Node Dissection for Locally Advanced Gastric Cancer (KLASS-02-RCT)
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|ClinicalTrials.gov Identifier: NCT01456598|
Recruitment Status : Active, not recruiting
First Posted : October 21, 2011
Last Update Posted : June 24, 2015
- It was confirmed that the laparoscopic surgery decreases the postoperative pain and reduces the recovery periods in the various surgical fields such as cholecystectomy and colectomy etc. Also, there are clinical evidences that the laparoscopic surgery is applicable to malignant tumor according to the development of surgical techniques and medical instruments.
- In case of early stage of gastric cancer, as the diverse clinical evidences, the gastrectomy has been commonly applied, however, the opening surgery is still applied for advanced gastric cancer due to lack of clinical evidence.
- In Korea, approximately 38% of patients who undergo surgery for gastric cancer are diagnosed by T2-T3 (AJCC 6th edition) (www.i-kgca.or.kr, National gastric cancer registration business in 2009). There are various clinical evidences to apply laparoscopic surgery to the patients, however, most of them are retrospective or cohort study results.
- For the clinical application of surgical treatment regarding locally advanced gastric cancer using laparoscopic surgical technique, it requires the confirmation of definite execution for laparoscopic gastrectomy and D2 lymph node dissection and the safety of surgery and oncological usefulness should be verified.
- In order for this, it is only possible to confirm through the comparison of short-term surgical results (complications, mortalities, operative time and duration of hospitalization etc) and long-term results (survival rates and recurrence rates etc) between laparoscopic surgery and opening surgery based on the multicenter large-sized randomized prospective study with current standard treatment.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Procedure: Laparoscopic gastrectomy Procedure: Open gastrectomy||Phase 3|
- Prior to this clinical trial, only the surgeons who are considered to have the standardization by participating the assignment entitled with "KLASS-02-QC: Standardization of D2 Lymphadenectomy and Surgical Quality Control for KLASS-02 Trial"(ClinicalTrials.gov No: NCT01283893).
- It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms.
- After rechecking the patients with the registration check list by accessing the web-based randomized program provided from Ajou University clinical trial center.
- The registration randomization should be done with 1:1 ratio for each researcher.
- Baseline number (BN) should be provided to the subjects in the order of acquisition of informed consent form. Based on the subjects who are selected as the appropriate subjects in the end, the allocation number (AN) shall be provided in the order of randomized allocation table.
- Operations are performed according to the allocated group.
- If it is under Stage II and Stage III in the final postoperative pathology, the adjuvant chemotherapy based on 5-FU.
Evaluation of efficacy and safety
- 3-year Relapse free survival rate and overall survival rate of the patients who undergo laparoscopic and open subtotal gastrectomy and D2 lymph node dissection.
- Analysis of recovery after laparoscopic and open subtotal gastrectomy and D2 lymph node dissection.
- Postoperative complications of the patients who undergo laparoscopic and open subtotal gastrectomy and D2 lymph node dissection within postoperative 3 weeks and later.
- The quality of life at preoperative, postoperative 25 days and 1 years using recovery index such as recovery of postoperative intestinal hypermotility, meals and duration of hospitalization, EORTC-C30 and STO22 questionnaire between the patients who underwent laparoscopic and open subtotal gastrectomy and D2 lymph node dissection.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1050 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Multicenter Randomized Controlled Clinical Trial for Comparison Between Laparoscopic and Open Subtotal Gastrectomy With D2 Lymph Node Dissection for Locally Advanced Gastric Cancer|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2018|
Experimental: Laparoscopic gastrectomy
Laparoscopic subtotal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer.
Procedure: Laparoscopic gastrectomy
Active Comparator: Open gastrectomy
Open subtotal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer.
Procedure: Open gastrectomy
- 3 year relapse free survival [ Time Frame: 36 months ]In terms of locally advanced gastric cancer, to examine the non-inferiority of disease free sur-vival rate in laparoscopic subtotal gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open subtotal gastrectomy with D2 lymph node dissection
- Early postoperative complication [ Time Frame: 3 weeks ]Early postoperative complication is defined as the events which occurs with-in postoperative 21 days, extension of hospitalization and rehospitaliation. It is necessary to evaluate the complication and if it occurs during the hospitalization, it is required to record complication name and date of on-set (postoperatively) and treatment for complication.
- Postoperative mortality [ Time Frame: 90 days ]It is defined as the death within postoperative 90 days regardless of postoperative reason. If the patient is transferred to other medication institutes with impossible condition for revocery be-fore death, it is regarded as death.
- Late postoperative complication [ Time Frame: 36 months ]Late postoperative complication is defined the events which occurs after postoperative 21 days. It is necessary to evaluate the complication. it is required to record complication name and date of on-set (postoperatively) and treatment for complication.
- Postoperative recovery index [ Time Frame: 1 week ]Postoperatively, the examiner evaluates the patient's recovery condition (gas exhaust) once a day. Evaluation items for patient's recovery condition: record the meal process once a day and inquire the pain score (10-scored scale) and blood test results at postoperative 2 and 5 days.
- Postoperative quality of life [ Time Frame: preoperative, 3 weeks, 12 months ]On preoperative, postoperative 3 weeks and postoperative 12 months, both EORTC-C30 and STO22 are analyzed with quality of life by following methods. In case of EORTC-C30, the analysis is undergone by classifying into 5 functional scales (physical, role, emotional, cognitive, and social fungtioning), 3 symptom scales (fatigue, pain and nausea, and vomiting), 1 global health status and 6 single items.
- 3 years overall survival [ Time Frame: 3 weeks, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months ]As one of the secondary endpoints, the overall survival rate in laparoscopic subtotal gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open subtotal gastrectomy with D2 lymph node dissection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01456598
|Korea, Republic of|
|Department of Surgery , SOON CHUN HYANG UNIVESITY HOSPITAL|
|Bucheon, Korea, Republic of|
|Keimyung University Dongsan Medical Center|
|Daegu, Korea, Republic of, 700-712|
|Copyright National Cancer Center|
|Goyang-si, Korea, Republic of|
|Chonnam National University Hwasun Hospital|
|Hwasun-gun, Korea, Republic of, 519-809|
|Incheon St, Mary's Hostpial, The Catholic University of Korea|
|Incheon, Korea, Republic of, 403-720|
|Dong-A University Hospital|
|Pusan, Korea, Republic of, 602-715|
|Department of Surgery, Seoul National University BUNDANG Hospital|
|Seongnam, Korea, Republic of|
|Department of Surgery, Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-799|
|Yonsei University Severance Hospital|
|Seoul, Korea, Republic of, 120-752|
|Yeoeuido St. Mary's Hospital, The Catholic University of Korea|
|Seoul, Korea, Republic of, 150-713|
|Department of surgery, GANGNAM SEVERANCE HOSPITAL|
|Seoul, Korea, Republic of|
|EWHA Womans university medical center|
|Seoul, Korea, Republic of|
|Ajou University Hospital|
|Suwon, Korea, Republic of, 443-749|
|Principal Investigator:||San-Uk Han, M.D., Ph.D.||Department of Surgery, Ajou University School of Medicine|