A Clinical Trial of D1+ Versus D2 Distal Gastrectomy for Stage IB & II Advanced Gastric Cancer
- Conditions
- Gastric Adenocarcinoma
- Interventions
- Procedure: D2 distal subtotal gastrectomyProcedure: D1+ distal subtotal gastrectomy
- Registration Number
- NCT02144727
- Lead Sponsor
- National Cancer Center, Korea
- Brief Summary
In oncological aspect, D1+ lymph node dissection would be enough for early stage gastric cancer in advanced gastric cancer (stage IB/IIA/IIB ).
- Detailed Description
■ Background of Hypothesis A. JCOG (Japanese Clinical Oncology Group) 9501 Study
: Addition of aorta lymph node dissection to D2 lymph node dissection does not increase survival rate.
Wide range of operation is not always the best treatment. If invasion rate can be kept as minimal as possible while maintaining survival rate, it can lead to more secure operation while also reducing the frequency of complication after the surgery. 20 It may be advantageous for patients in terms of operation time, cost, and quality of life.
B. COACT 1001 study A previous study which compared the feasibility of lymph node dissection in open surgery and lapraroscopic surgery for advanced gastric cancer.
11p, 12a lymph node (D2) resection rate: 79.2% and 88.8% respectively in all advance gastric cancer.
11p, 12a lymph node (D2) metastasis rate: 1.9% and 2.9% respectively. Subgroup analysis 11p, 12a lymph node resection in cStage IB/IIA: 74.5-80.0% and 86.7-96.1% respectively. : 0% metastasis rate for both.
lymph node dissection in cStage IIB/IIIA: 81.1-82.3% and 87.5-89.2% respectively.: metastasis rates are 2.1% and 2.4-12.1% respectively.
Application: 11p and 12a lymph nodes, which belong in D2 lymph nodes, need to be resected in advance gastric cancer in IIB stage or higher. However, in earlier stages of advance gastric cancer, the probability of metastasis is very low; therefore, resection of D1+ lymph nodes, excluding 11p and 12a, is enough.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1880
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description D2 distal subtotal gastrectomy D2 distal subtotal gastrectomy D2 distal subtotal gastrectomy D2 includes Nos.1.3,4sb,4d,5,6,7,8a,9,11p,and 12a nodes in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy D1+ distal subtotal gastrectomy D1+ distal subtotal gastrectomy D1+ distal subtotal gastrectomy D1+ includes Nos.1,3,4sb,4d,5,6,7,8a,and 9 nodes in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy
- Primary Outcome Measures
Name Time Method overall survival 5 year To test non-inferiority of survival of D1+ gastrectomy versus D2 gastrectomy for clinical stage I B \& II advanced gastric cancer
- Secondary Outcome Measures
Name Time Method Long term postoperative complications after 30 days Long term postoperative complications
Operating time op day Operating time
disease free survival 3 year 3 year disease free survival
Overall cost for the treatment operation day to discharge Overall cost for the treatment (from operative day to discharge day)
Subgroup analysis of Laparoscopic surgery versus open surgery 3 year , 5 year Subgroup analysis of Laparoscopic surgery versus open surgery in terms of 3 year relapse free survival and 5 year overall survival
Early postoperative complications within 30 days Early postoperative complications
Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D) baseline, 1 week, 1month, 6 month, 1 year, 3 year Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)
Finding biomarkers predicting lymph node metastasis and recurrence 3 year Finding biomarkers predicting lymph node metastasis and recurrence for prediction of lymph node metastasis and recurrence
Trial Locations
- Locations (50)
National Cancer Center
🇰🇷Goyang, Gyunggi-Do, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Konyang University Hospital
🇰🇷Metropolitan City Daejon, Daejon, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan
🇰🇷Cheonan, Chuncheongnam-Do, Korea, Republic of
The Catholic University of Korea St. Vincent's Hospital
🇰🇷Suwon, Gyeonggi-Do, Korea, Republic of
Dongguk University Medical Center
🇰🇷Goyang, Gyeonggi-Do, Korea, Republic of
Kangwon National University Hospital
🇰🇷Chuncheon, Gangwon-Do, Korea, Republic of
Dongguk University Gyeongju Hospital
🇰🇷Gyeongju, Gyeongbuk, Korea, Republic of
Gyengsang National University Hospital
🇰🇷Jinjoo, Gyeongsangnam-Do, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Gyeonggi-Do, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan, Gyeonggi-Do, Korea, Republic of
Hanyang University Guri Hospital
🇰🇷Guri, Gyeonggi-do, Korea, Republic of
Jeju National University Hospital
🇰🇷Jeju, Jeju Special Self-Governing Province, Korea, Republic of
Chosun University Hospital
🇰🇷Gwangju, Jellanam-Do, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun-Gun, Jellanam-Do, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Jellabuk-Do, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Dongnam Inst. Of Radiological & Medical Sciences
🇰🇷Busan, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Kungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Daegu Catholic Univ. Medical Center
🇰🇷Daegu, Korea, Republic of
Daegu Veterans Hospital
🇰🇷Daegu, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Gachon University Gill Medical Center
🇰🇷Incheon, Korea, Republic of
The Catholic University of Korea Incheon St. Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Seoul Red Cross Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
KyungHee University Medical Center
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of
Hanyang University Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
VHS Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Soon Chun Hyang University Hospital Seoul
🇰🇷Seoul, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Korea Cancer Center Hospital
🇰🇷Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Medical Center
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of