A Clinical Trial of D1+ Versus D2 Distal Gastrectomy for Stage IB & II Advanced Gastric Cancer
Conditions
Gastric Adenocarcinoma
Conditions: official terms
Adenocarcinoma
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: D2 distal subtotal gastrectomy Type: Procedure
Name: D1+ distal subtotal gastrectomy Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria :

- Histologically proven primary gastric adenocarcinoma

- T2N0, T2N1, T3N0, T3N1, which are assessed by computed tomography (CT) scan (AJCC 7th classification) and intraoperative surgical staging prior to resectional procedure

- Location of primary tumor; antrum, or angle, or lower body of the stomach

- No evidence of other distant metastasis

- Aged 20-80 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:

- WBC 3000/mm3 - 12,000/mm3

- >serum Hemoglobin 8.0 g/dl

- > serum Platelet 100 000/mm3

- < serum AST 100 IU/l

-
- < Total Bilirubin 2.0 mg/dl

- Written signed informed consent

Exclusion Criteria :

- Active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer)

- Gastric remnant cancer

- ≥T4a in surgical staging before resection

- N2 or more (number of metastatic lymph nodes ≥3) in CT scan

- histologically rare variants in WHO Classification such as Adenosquamous

- Hepatoid, Squamous cell, Undifferentiated, and others

- Pregnant or breast-feeding women

- severe mental disorder

- systemic administration of corticosteroids(include Herbal Medication)

- unstable angina or myocardial infarction within 6 months of the trial

- unstable hypertension

- severe respiratory disease requiring continuous oxygen therapy

- previous upper abdominal surgery except laparoscopic cholecystectomy
Locations
Soon Chun Hyang University Hospital Cheonan
Cheonan, Chuncheongnam-Do, Korea, Republic of
Status: Not yet recruiting
Contact: Moon Soo Lee, Dr - +82-41-570-2114
Konyang University Hospital
Metropolitan City Daejon, Daejon, Korea, Republic of
Status: Not yet recruiting
Contact: Sang Eok Lee, Dr - +82-10-6432-6399 - srglee@hanmail.net
Kangwon National University Hospital
Chuncheon, Gangwon-Do, Korea, Republic of
Status: Not yet recruiting
Contact: Sung Bae Park, Dr - +82-10-2001-8566 - bsb1971_kr@kangwon.ac.kr
Dongguk University Gyeongju Hospital
Gyeongju, Gyeongbuk, Korea, Republic of
Status: Not yet recruiting
Contact: Jung Min Bae, Dr - +82-54-770-8217
Korea University Ansan Hospital
Ansan, Gyeonggi-Do, Korea, Republic of
Status: Not yet recruiting
Contact: Jong Han Kim, Dr - +82-31-412-5030 - ppongttai@gmail.com
Dongguk University Medical Center
Goyang, Gyeonggi-Do, Korea, Republic of
Status: Not yet recruiting
Contact: Yong Hae Baik, Dr - +82-10-6320-9229 - Whitedrag@naver.com
Hanyang University Guri Hospital
Guri, Gyeonggi-do, Korea, Republic of
Status: Not yet recruiting
Contact: Min Gyu Kim, Dr - +82-31-560-2114
Ajou University Hospital
Suwon, Gyeonggi-Do, Korea, Republic of
Status: Not yet recruiting
Contact: Sang-Uk Han, Dr - +82-10-2911-9336 - hansu@ajou.ac.kr
The Catholic University of Korea St. Vincent's Hospital
Suwon, Gyeonggi-Do, Korea, Republic of
Status: Not yet recruiting
Contact: Hyung Min Chin, Dr - +82-31-249-7170 - hchin@catholic.ac.kr
Gyengsang National University Hospital
Jinjoo, Gyeongsangnam-Do, Korea, Republic of
Status: Not yet recruiting
Contact: Young Joon Lee, Dr - +82-10-5060-3214 - orangejulia@naver.com
National Cancer Center
Goyang, Gyunggi-Do, Korea, Republic of
Status: Recruiting
Contact: Young Woo Kim, PhD. - +82-31-920-1635 - gskim@ncc.re.kr
Jeju National University Hospital
Jeju, Jeju Special Self-Governing Province, Korea, Republic of
Status: Not yet recruiting
Contact: In Ho Jeong, Dr - +82-10-3644-2240 - 41056@naver.com
Chonbuk National University Hospital
Jeonju, Jellabuk-Do, Korea, Republic of
Status: Not yet recruiting
Contact: Doo Hyun Yang, Dr - +82-10-4905-6291 - ydh@chonbuk.ac.kr
Chosun University Hospital
Gwangju, Jellanam-Do, Korea, Republic of
Status: Not yet recruiting
Contact: Young Don Min, Dr - +82-62-220-3114
Chonnam National University Hwasun Hospital
Hwasun-Gun, Jellanam-Do, Korea, Republic of
Status: Not yet recruiting
Contact: Young Kyu Park, Dr - +82-10-7173-1196 - parkyk@jnu.ac.kr
Dong-A University Hospital
Busan, Korea, Republic of
Status: Not yet recruiting
Contact: Ki-Han Kim, Dr - +82-51-240-2643
Dongnam Inst. Of Radiological & Medical Sciences
Busan, Korea, Republic of
Status: Not yet recruiting
Contact: Jae-Seok Min, Dr - +82-10-9567-9488 - mdoogy@hanmail.net
Inje University Haeundae Paik Hospital
Busan, Korea, Republic of
Status: Not yet recruiting
Contact: Byoung-Jo Suh, Dr - +82-11-899-7365 - oltx62@hotmail.com
Kosin University Gospel Hospital
Busan, Korea, Republic of
Status: Not yet recruiting
Contact: Sang Ho Lee, Dr - +82-10-2867-8177 - gslsh@kosinmed.or.kr
Pusan National University Hospital
Busan, Korea, Republic of
Status: Not yet recruiting
Contact: Dong Heon Kim, Dr - +82-10-4004-1134 - kdhun@pusan.ac.kr
Daegu Catholic Univ. Medical Center
Daegu, Korea, Republic of
Status: Not yet recruiting
Contact: Hyun Dong Chae, Dr - +82-53-650-4065 - surgery@cu.ac.kr
Daegu Veterans Hospital
Daegu, Korea, Republic of
Status: Not yet recruiting
Contact: Taebong Kim, Dr - +82-10-4137-8022 - tkimchr@medigate.net
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
Status: Not yet recruiting
Contact: Seung Wan Ryu, Dr - +82-11-522-9659 - gsman@dsmc.or.kr
Kungpook National University Hospital
Daegu, Korea, Republic of
Status: Not yet recruiting
Contact: Wansik Yu, Dr - +82-10-9069-0365 - wyu@knu.ac.kr
Kyungpook National University Hospital
Daegu, Korea, Republic of
Status: Not yet recruiting
Contact: Ho Young Chung, Dr - +82-53-200-5601
Yeungnam University Medical Center
Daegu, Korea, Republic of
Status: Not yet recruiting
Contact: Se Won Kim, Dr - kswgs@ynu.ac.kr
Chungnam National University Hospital
Daejeon, Korea, Republic of
Status: Not yet recruiting
Contact: Ji Young Sul, Dr - +82-10-5420-8369 - jsul@cnu.ac.kr
Gachon University Gill Medical Center
Incheon, Korea, Republic of
Status: Not yet recruiting
Contact: Woon Ki Lee, Dr - +82-10-8945-6007 - lwk@gilhospital.com
Inha University Hospital
Incheon, Korea, Republic of
Status: Not yet recruiting
Contact: Yoon Seok Heo, Dr - +82-32-890-3431 - gshur@inha.ac.kr
The Catholic University of Korea Incheon St. Mary's Hospital
Incheon, Korea, Republic of
Status: Not yet recruiting
Contact: Jinjo Kim, Dr - +82-2-1544-9004 - kjj@catholic.ac.kr
Asan Medical Center
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Jeong Hwan Yook, Dr - +82-10-2258-8826 - jhyook@amc.seoul.kr
Chung-Ang University Hospital
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Kyeung Chun Chi, Dr - +82-16-649-9874 - kcchi@cau.ac.kr
Ewha Womans University Medical Center
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Joo Ho Lee, Dr - gsljh@ewha.ac.kr
Gangnam Severance Hospital
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Seung-Ho Choi, Dr - +82-10-3276-1466 - choish@yumc.yonsei.ac.kr
Hallym University Sacred Heart Hospital
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Man Sup Lim, Dr - +82-10-3270-2988 - ellemes@hanmail.net
Hanyang University Medical Center
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Sung Joon Kwon, Dr - +82-10-2014-4398 - sjkwon@hanyang.ac.kr
Konkuk University Medical Center
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Ho-Yoon Bang, Dr - +82-10-6297-0629 - bangstca@kcch.re.kr
Korea Cancer Center Hospital
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Hang Jong Yu, Dr - +82-10-9253-5463 - imyst@hanafos.com
Korea University Anam Hospital
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Seong Heum Park, Dr - +82-10-8992-3973 - pshchw@korea.ac.kr
Korea University Guro Hospital
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Young Jae Mok, Dr - +82-10-2686-6587 - yjmok@kumc.ac.kr
Kyung Hee University Hospital at Gangdong
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Sung Il Choi, Dr - +82-10-3974-1654 - drchoi@khu.ac.kr
KyungHee University Medical Center
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Yong Ho Kim, Dr - +82-10-6540-8262 - kyjho@khmc.or.kr
Samsung Medical Center
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Jae-Moon Bae, Ph.D - +82-10-8843-1625 - jmoonbae60@yahoo.co.kr
Seoul National University Hospital
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Han-Kwang Yang, Dr - +82-10-5216-0032 - hkyang@snu.ac.kr
Seoul Red Cross Hospital
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Dong Gue Shin, Dr - +82-2-2002-8380 - shinedk@seoulmc.or.kr
Severance Hospital
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Woo-Jin Hyung, Dr - +82-2-2228-5170
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Hye Sung Ahn, Dr - +82-2-2072-3797
Soon Chun Hyang University Hospital Seoul
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Yong Jin Kim, Dr - +82-10-5382-6758 - yjkim@hosp.sch.ac.kr
The Catholic University of Korea St. Mary's Hospital
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Hae-Myung Jeon, Dr - +82-10-9066-5231 - hmjeon@catholic.ac.kr
VHS Medical Center
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Ho-Geun Yoon, Dr - +82-2-2225-1234
Start Date
January 2014
Completion Date
December 2021
Sponsors
National Cancer Center, Korea
Source
National Cancer Center, Korea
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page