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

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:

MedlinePlus related topics: Cancer Stomach Cancer

U.S. FDA Resources

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

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

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
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.
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.
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.
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.
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, Jilin
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
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.
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.
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.

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:

Southern Medical University, China This link exits the ClinicalTrials.gov site

Nanfang Hospital, China This link exits the ClinicalTrials.gov site

Chinese Anti-Cancer Association This link exits the ClinicalTrials.gov site

Publications:

Huscher CG, Mingoli A, Sgarzini G, Sansonetti A, Di Paola M, Recher A, Ponzano C. Laparoscopic versus open subtotal gastrectomy for distal gastric cancer: five-year results of a randomized prospective trial. Ann Surg. 2005 Feb;241(2):232-7.

Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20.

Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20.

Songun I, Putter H, Kranenbarg EM, Sasako M, van de Velde CJ. Surgical treatment of gastric cancer: 15-year follow-up results of the randomised nationwide Dutch D1D2 trial. Lancet Oncol. 2010 May;11(5):439-49. Epub 2010 Apr 19.

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:	December 26, 2012
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
Gastrointestinal Neoplasms
Digestive System Neoplasms

Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on June 18, 2013