Multicenter Study on Laparoscopic Distal Subtotal Gastrectomy for Advanced Gastric Cancer (CLASS-01)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Nanfang Hospital of Southern Medical University
Sponsor:
Information provided by (Responsible Party):
Guoxin Li, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT01609309
First received: May 29, 2012
Last updated: June 23, 2014
Last verified: June 2014
  Purpose
  • Laparoscopic distal subtotal gastrectomy with lymph node dissection as minimally invasive surgery has gained popularity for the treatment of early gastric cancer in East Asian countries, even though the long-term follow-up outcome based on multicenter randomized clinical trial (RCT) is still awaited.
  • For the patient with locally advanced gastric cancer, several studies indicated that laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. However, the application of it is controversial mainly due to lack of solid evidence on the oncologic efficacy. Therefore, conventional open approach is still the current standard for advanced gastric cancer.
  • Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 80 per cent of all gastric cancer cases in China. Before the clinical application of laparoscopic procedure for the treatment with curative intent to advanced gastric cancer located at the middle- or lower-third of the stomach, the oncologic efficacy must be verified.
  • Accordingly, the comparison of long-term outcome between laparoscopic and open distal subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer based on a well designed multicenter RCT is needed.

Condition Intervention Phase
Stomach Neoplasms
Procedure: Laparoscopic gastrectomy
Procedure: Open gastrectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Study on Comparison of Long-term Outcome Between Laparoscopic and Open Distal Subtotal Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Nanfang Hospital of Southern Medical University:

Primary Outcome Measures:
  • 3-year disease free survival rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morbidity and mortality [ Time Frame: 30 days; 36 months ] [ Designated as safety issue: Yes ]
    The early postoperative complication and mortality are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th.

  • 3-year overall survival rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • 3-year recurrence pattern [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.

  • Postoperative recovery course [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    • Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recoverty course.
    • The amount of abdominal drainage and blood transfusion are also recorded.

  • Inflammatory and immune response [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    The daily highest body temperature before discharge and the values of white blood cell count, hemoglobin, C-reactive protein, prealbumin and relevant immune cytokines including IL-6, T cell count, T-helper lymphocytes (CD4+) count, T-suppressor lymphocytes (CD8+) count, natural killer (NK) cells count, B-lymphocytes count, and TNF-α from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.


Estimated Enrollment: 1056
Study Start Date: September 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laparoscopic gastrectomy
Laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
Procedure: Laparoscopic gastrectomy
  • After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, laparoscopic distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent.
  • The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy.
Other Name: LDG
Active Comparator: Open gastrectomy
Open distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
Procedure: Open gastrectomy
  • After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, open distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent.
  • The type of reconstruction will be selected according to the surgeon's experience.
Other Name: ODG

  Eligibility

Ages Eligible for Study:   19 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age from over 18 to under 75 years
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • cT2-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
  • Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy
  • Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
  • ASA (American Society of Anesthesiology) score class I, II, or III
  • Written informed consent

Exclusion Criteria:

  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
  • Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
  • History of other malignant disease within past five years
  • History of previous neoadjuvant chemotherapy or radiotherapy
  • History of unstable angina or myocardial infarction within past six months
  • History of cerebrovascular accident within past six months
  • History of continuous systematic administration of corticosteroids within one month
  • Requirement of simultaneous surgery for other disease
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • FEV1<50% of predicted values
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609309

Contacts
Contact: Guoxin Li, M.D., Ph.D. +86-138-0277-1450 gzliguoxin@163.com
Contact: Yanfeng Hu, M.D. +86-136-3249-4551 huyanfenger@vip.tom.com

Locations
China, Beijing
The People's Liberation Army General Hospital Recruiting
Beijing, Beijing, China, 100-853
Contact: Xiaohui Du, M.D., Ph.D.    +86-138-0130-0826    Duxiaohui301@sina.com   
Principal Investigator: Xiaohui Du, M.D., Ph.D.         
Peking University Cancer Hospital Recruiting
Beijing, Beijing, China, 100-142
Contact: Ziyu Li, M.D., Ph.D.    +86-139-0100-9767    ligregory369@hotmail.com   
Principal Investigator: Ziyu Li, M.D.,Ph.D.         
Principal Investigator: Xiangqian Su, M.D., Ph.D         
China, Fujian
Fujian Medical University Union Hospital Recruiting
Fuzhou, Fujian, China, 350-001
Contact: Changming Huang, M.D., Ph.D.    +86-133-6591-0253    hcmlr253@sohu.com   
Principal Investigator: Changming Huang, M.D., Ph.D.         
Fujian Provincial Cancer Hospital Recruiting
Fuzhou, Fujian, China, 350-014
Contact: Mingang Ying, M.D., Ph.D.    0086-13906906675    yingmg@163.com   
Contact: Weidong Zang, M.D.    0086-13805066578    894434459@qq.com   
Principal Investigator: Mingang Ying, M.D., Ph.D.         
China, Guangdong
Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510-515
Contact: Guoxin Li, M.D., Ph.D.    +86-138-0277-1450    gzliguoxin@163.com   
Contact: Yanfeng Hu, M.D.    +86-136-3249-4551    huyanfenger@vip.tom.com   
Principal Investigator: Guoxin Li, M.D.,Ph.D.         
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Yong Li, M.D., Ph.D.    0086-13822177479    liyong-lucky@21cn.com   
Contact: Deqing Wu, M.D., Ph.D.    0086-13902301120    13902301120@139.com   
Principal Investigator: Yong Li, M.D., Ph.D.         
The Third Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510-630
Contact: Hong-Bo Wei, M.D., Ph.D.    0086-18922102969    drweihb@126.com   
Contact: Bo Wei, M.D.    0086-13527794069    sanpi2013@163.com   
Principal Investigator: Hong-Bo Wei, M.D., Ph.D.         
China, Heilongjiang
Harbin Medical University Cancer Hospital Recruiting
Harbin, Heilongjiang, China, 150-081
Contact: Yingwei Xue, M.D., Ph.D.    +86-138-3603-8693    kevinwl@163.com   
Principal Investigator: Yingwei Xue, M.D., Ph.D.         
China, Hubei
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430022
Contact: Kaixiong Tao, M.D., Ph.D.    0086-13507155452    tao_kaixiong@163.com   
Contact: Xiaoming Shuai, M.D., Ph.D.    0086-13986297548    xmshuai@hust.edu.cn   
Principal Investigator: Kaixiong Tao, M.D., Ph.D.         
China, Jiangsu
Jinling Hospital, School of Medicine, Nanjing University Recruiting
Nanjing, Jiangsu, China, 210-002
Contact: Zhiwei Jiang, M.D., Ph.D.    0086-13951630229    surery34@163.com   
Contact: Gang Wang, M.D.    0086-13390907882    gwang82@163.com   
Principal Investigator: Zhiwei Jiang, M.D., Ph.D.         
China, Jilin
The Bethune First Hospital Jilin University Recruiting
Changchun, Jilin, China, 130021
Contact: Jian Suo, M.D.    0086-13756661293    suojian0066@126.com   
Contact: Yang Zhang, M.D.    0086-13610712293    100981024@qq.com   
Principal Investigator: Jian Suo, M.D., Ph.D.         
The Second Hospital of Jilin University Recruiting
Changchun, Jilin, China, 130-041
Contact: Xuedong Fang, M.D., Ph.D.    +86-135-1440-6378    wangxudong1971@126.com   
Principal Investigator: Xuedong Fang, M.D., Ph.D.         
China, Shanghai
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200-032
Contact: Yihong Sun, M.D., Ph.D.    +86-137-0173-5406    yihongsun@medmail.com.cn   
Principal Investigator: Yihong Sun, M.D., Ph.D.         
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200-025
Contact: Weiguo Hu, M.D., Ph.D.    +86-135-0186-0025    wghusurgeon@hotmail.com   
Principal Investigator: Weiguo Hu, M.D., Ph.D.         
China, Shanxi
Tangdu Hospital, the Fourth Military Medical University Recruiting
Xi'an, Shanxi, China, 710-038
Contact: Xianli He, M.D., Ph.D.    0086-13991359527    oldfan@fmmu.edu.cn   
Contact: Nan Wang, M.D.    0086-13630229267    wangnandoc@163.com   
Principal Investigator: Xianli He, M.D., Ph.D.         
China, Sichuan
West China Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610-041
Contact: Jiankun Hu, M.D., Ph.D.    +86-189-8060-1504    hujkwch@126.com   
Principal Investigator: Jiankun Hu, M.D.,Ph.D.         
China
Renji Hospital ,Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, China, 200-127
Contact: Gang Zhao, M.D., Ph.D.    0086-13701958141    zhaogang74313@yahoo.com.cn   
Contact: Chunchao Zhu, M.D.    0086-13917100568    zcczmy@hotmail.com   
Principal Investigator: Gang Zhao, M.D., Ph.D.         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
Principal Investigator: Guoxin Li, M.D., Ph.D. Chinese Laparoscopic Gastrointestinal Surgical Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China
  More Information

Additional Information:
Publications:
Responsible Party: Guoxin Li, M.D., Ph.D., Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01609309     History of Changes
Other Study ID Numbers: CLASS - 01
Study First Received: May 29, 2012
Last Updated: June 23, 2014
Health Authority: China: Ministry of Health

Keywords provided by Nanfang Hospital of Southern Medical University:
Stomach Neoplasms
Laparoscopy

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Site
Stomach Diseases

ClinicalTrials.gov processed this record on October 29, 2014