Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In oncological aspect, D1+ lymph node dissection would be enough for early stage gastric cancer in advanced gastric cancer (stage IB/IIA/IIB ).
â– 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D2 distal subtotal gastrectomy | Active Comparator | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D2 distal subtotal gastrectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | To test non-inferiority of survival of D1+ gastrectomy versus D2 gastrectomy for clinical stage I B & II advanced gastric cancer | 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| disease free survival | 3 year disease free survival | 3 year |
| Subgroup analysis of Laparoscopic surgery versus open surgery | Subgroup analysis of Laparoscopic surgery versus open surgery in terms of 3 year relapse free survival and 5 year overall survival |
Not provided
Inclusion Criteria :
Histologically proven primary gastric adenocarcinoma
T1N1, T2N0, T2N1, T3N0, T3N1 by CT scan (AJCC 7th classification) and intraoperative surgical staging prior to resectional procedure
Location of primary tumor; antrum, or angle, lower body or mid body of the stomach
No evidence of other distant metastasis
Aged ≥ 20 year old
Performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
No prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection
Adequate organ functions defined as indicated below:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young Woo Kim, Ph.D | Contact | 82-31-920-1635 | gskim@ncc.re.kr |
| Name | Affiliation | Role |
|---|---|---|
| Young Woo Kim, PhD | National Cancer Center, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kosin University Gospel Hospital | Not yet recruiting | Busan | Busan | 602-702 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D1+ distal subtotal gastrectomy | Procedure | 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 |
|
| 3 year , 5 year |
| Operating time | Operating time | op day |
| Early postoperative complications | Early postoperative complications | within 30 days |
| Long term postoperative complications | Long term postoperative complications | after 30 days |
| Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D) | 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 |
| Overall cost for the treatment | Overall cost for the treatment (from operative day to discharge day) | operation day to discharge |
| Finding biomarkers predicting lymph node metastasis and recurrence | Finding biomarkers predicting lymph node metastasis and recurrence for prediction of lymph node metastasis and recurrence | 3 year |
| Pusan National University Hospital | Not yet recruiting | Busan | Busan | 602-739 | South Korea |
|
| Dong-A University Hospital | Not yet recruiting | Busan | Busan | 602-812 | South Korea |
|
| Dongnam Inst. Of Radiological & Medical Sciences | Not yet recruiting | Busan | Busan | 619-953 | South Korea |
|
| Inje University Haeundae Paik Hospital | Not yet recruiting | Busan | Busan | Busan 612-896 | South Korea |
|
| Soon Chun Hyang University Hospital Cheonan | Not yet recruiting | Cheonan | Chuncheongnam-Do | 330-721 | South Korea |
|
| Keimyung University Dongsan Medical Center | Not yet recruiting | Daegu | Daegu | 700-712 | South Korea |
|
| Kyungpook National University Hospital | Not yet recruiting | Daegu | Daegu | 700-721 | South Korea |
|
| Kungpook National University Hospital | Not yet recruiting | Daegu | Daegu | 702-210 | South Korea |
|
| Daegu Veterans Hospital | Not yet recruiting | Daegu | Daegu | 704-802 | South Korea |
|
| Yeungnam University Medical Center | Not yet recruiting | Daegu | Daegu | 705-703 | South Korea |
|
| Daegu Catholic Univ. Medical Center | Not yet recruiting | Daegu | Daegu | 705-718 | South Korea |
|
| Chungnam National University Hospital | Not yet recruiting | Daejeon | Daejeon | 301-721 | South Korea |
|
| Konyang University Hospital | Not yet recruiting | Metropolitan City Daejon | Daejon | 302-718 | South Korea |
|
| Kangwon National University Hospital | Not yet recruiting | Chuncheon | Gangwon-do | 200-722 | South Korea |
|
| Korea University Ansan Hospital | Not yet recruiting | Ansan | Gyeonggi-do | 425-707 | South Korea |
|
| Dongguk University Medical Center | Not yet recruiting | Goyang-si | Gyeonggi-do | 410-773 | South Korea |
|
| Hanyang University Guri Hospital | Not yet recruiting | Guri-si | Gyeonggi-do | 471-701 | South Korea |
|
| The Catholic University of Korea St. Vincent's Hospital | Not yet recruiting | Suwon | Gyeonggi-do | 442-723 | South Korea |
|
| Ajou University Hospital | Not yet recruiting | Suwon | Gyeonggi-do | 443-380 | South Korea |
|
| Dongguk University Gyeongju Hospital | Not yet recruiting | Gyeongju | Gyeongsangbuk-do | 780-350 | South Korea |
|
| Gyengsang National University Hospital | Not yet recruiting | Jinjoo | Gyeongsangnam-do | 660-702 | South Korea |
|
| National Cancer Center | Recruiting | Goyang | Gyunggi-Do | 410-769 | South Korea |
|
| Inha University Hospital | Not yet recruiting | Incheon | Incheon | 400-711 | South Korea |
|
| The Catholic University of Korea Incheon St. Mary's Hospital | Not yet recruiting | Incheon | Incheon | 403-720 | South Korea |
|
| Gachon University Gill Medical Center | Not yet recruiting | Incheon | Incheon | 405-760 | South Korea |
|
| Jeju National University Hospital | Not yet recruiting | Jeju City | Jeju Special Self-Governing Province | 690-767 | South Korea |
|
| Chonbuk National University Hospital | Not yet recruiting | Jeonju | Jellabuk-Do | 561-712 | South Korea |
|
| Chosun University Hospital | Not yet recruiting | Gwangju | Jellanam-Do | 501-717 | South Korea |
|
| Chonnam National University Hwasun Hospital | Not yet recruiting | Hwasun-Gun | Jellanam-Do | 519-763 | South Korea |
|
| Seoul National University Hospital | Not yet recruiting | Seoul | Seoul | 110-744 | South Korea |
|
| Seoul Red Cross Hospital | Not yet recruiting | Seoul | Seoul | 110-747 | South Korea |
|
| Severance Hospital | Not yet recruiting | Seoul | Seoul | 120-752 | South Korea |
|
| KyungHee University Medical Center | Not yet recruiting | Seoul | Seoul | 130-872 | South Korea |
|
| Hanyang University Medical Center | Not yet recruiting | Seoul | Seoul | 133-792 | South Korea |
|
| Kyung Hee University Hospital at Gangdong | Not yet recruiting | Seoul | Seoul | 134-727 | South Korea |
|
| VHS Medical Center | Not yet recruiting | Seoul | Seoul | 134-791 | South Korea |
|
| Samsung Medical Center | Not yet recruiting | Seoul | Seoul | 135-710 | South Korea |
|
| Gangnam Severance Hospital | Not yet recruiting | Seoul | Seoul | 135-720 | South Korea |
|
| Korea University Anam Hospital | Not yet recruiting | Seoul | Seoul | 136-705 | South Korea |
|
| The Catholic University of Korea St. Mary's Hospital | Not yet recruiting | Seoul | Seoul | 137-701 | South Korea |
|
| Asan Medical Center | Not yet recruiting | Seoul | Seoul | 138-736 | South Korea |
|
| Korea Cancer Center Hospital | Not yet recruiting | Seoul | Seoul | 139-709 | South Korea |
|
| Soon Chun Hyang University Hospital Seoul | Not yet recruiting | Seoul | Seoul | 140-887 | South Korea |
|
| Konkuk University Medical Center | Not yet recruiting | Seoul | Seoul | 143-729 | South Korea |
|
| Hallym University Sacred Heart Hospital | Not yet recruiting | Seoul | Seoul | 150-037 | South Korea |
|
| Korea University Guro Hospital | Not yet recruiting | Seoul | Seoul | 152-703 | South Korea |
|
| SMG-SNU Boramae Medical Center | Not yet recruiting | Seoul | Seoul | 156-707 | South Korea |
|
| Chung-Ang University Hospital | Not yet recruiting | Seoul | Seoul | 156-755 | South Korea |
|
| Ewha Womans University Medical Center | Not yet recruiting | Seoul | Seoul | 158-710 | South Korea |
|