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

NCT01609309 | Unknown Phase 3 DMC

• 1 other identifier: CLASS - 01
• Study Type: interventional
• Target: 1,056
• Locations: 1 country
• Sites: 14

Brief Summary

• 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 intraoperative and postoperative complications between laparoscopic and open distal subtotal gastrectomy for over 65 years old patients with gastric cancer based on a randomized controlled trial is needed.

Conditions

Stomach Neoplasms

Keywords

Stomach Neoplasms; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• 3-year disease free survival rate

  36 months

Secondary Outcomes (5)

• Morbidity and mortality

  30 days; 36 months

• 3-year overall survival rate

  36 months

• 3-year recurrence pattern

  36 months

• Postoperative recovery course

  10 days

• Inflammatory and immune response

  7 days

Study Arms (2)

Laparoscopic gastrectomy

EXPERIMENTAL

Laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.

Procedure: Laparoscopic gastrectomy

Open gastrectomy

ACTIVE COMPARATOR

Open distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.

Procedure: Open gastrectomy

Interventions

Laparoscopic gastrectomy PROCEDURE

* 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.

Also known as: LDG

Laparoscopic gastrectomy

Open gastrectomy PROCEDURE

* 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.

Also known as: ODG

Open gastrectomy

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (14)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100-142, China

Location

The People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100-853, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350-001, China

Location

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, 350-014, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510-515, China

Location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510-630, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150-081, China

Location

Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

The Bethune First Hospital Jilin University

Changchun, Jilin, 130021, China

Location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200-025, China

Location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200-032, China

Location

Tangdu Hospital, the Fourth Military Medical University

Xi’an, Shanxi, 710-038, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610-041, China

Location

Renji Hospital ，Shanghai Jiao Tong University School of Medicine

Shanghai, 200-127, China

Location

Related Publications (9)

• 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. doi: 10.1097/01.sla.0000151892.35922.f2.

  PMID: 15650632 BACKGROUND

• 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. doi: 10.1056/NEJMoa072252.

  PMID: 17978289 BACKGROUND

• 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. doi: 10.1097/SLA.0b013e3181cc8f6b.

  PMID: 20160637 BACKGROUND

• 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. doi: 10.1016/S1470-2045(10)70070-X. Epub 2010 Apr 19.

  PMID: 20409751 BACKGROUND

• Wei LH, Zheng HL, Liu ZY, Du XQ, Chen CS, Xu BB, Zheng HH, Lin GT, Xie JW, Zheng CH, Wang JB, Huang CM, Li P. Preoperative visceral fat area predicts intraoperative adverse events during lymphadenectomy in laparoscopic gastrectomy for gastric cancer: a post hoc analysis. Surg Endosc. 2025 Apr;39(4):2275-2287. doi: 10.1007/s00464-025-11602-x. Epub 2025 Feb 12.

  PMID: 39937241 DERIVED

• Liu ZY, Chen QY, Zhong Q, Li P, Xie JW, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Huang CM, Zheng CH. Intraoperative Adverse Events, Technical Performance, and Surgical Outcomes in Laparoscopic Radical Surgery for Gastric Cancer: A Pooled Analysis From 2 Randomized Trials. Ann Surg. 2023 Aug 1;278(2):222-229. doi: 10.1097/SLA.0000000000005727. Epub 2022 Oct 17.

  PMID: 36250322 DERIVED

• Huang C, Liu H, Hu Y, Sun Y, Su X, Cao H, Hu J, Wang K, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Yu J, Zheng C, Liu F, Li Z, Zhao G, Zhang J, Chen P, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Laparoscopic vs Open Distal Gastrectomy for Locally Advanced Gastric Cancer: Five-Year Outcomes From the CLASS-01 Randomized Clinical Trial. JAMA Surg. 2022 Jan 1;157(1):9-17. doi: 10.1001/jamasurg.2021.5104.

  PMID: 34668963 DERIVED

• Ji JF. [Chinese standard and milestone of laparoscopic surgery for gastric cancer--Comments on the publishing of "Standard Operation Procedure of Laparoscopic surgery from CLASS-01 trial"]. Zhonghua Wei Chang Wai Ke Za Zhi. 2019 Oct 25;22(10):913-915. doi: 10.3760/cma.j.issn.1671-0274.2019.10.002. Chinese.

  PMID: 31630485 DERIVED

• Yu J, Huang C, Sun Y, Su X, Cao H, Hu J, Wang K, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Hu Y, Liu H, Zheng C, Li P, Xie J, Liu F, Li Z, Zhao G, Yang K, Liu C, Li H, Chen P, Ji J, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer: The CLASS-01 Randomized Clinical Trial. JAMA. 2019 May 28;321(20):1983-1992. doi: 10.1001/jama.2019.5359.

  PMID: 31135850 DERIVED

Related Links

• Southern Medical University, China
• Nanfang Hospital, China
• Chinese Anti-Cancer Association

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Guoxin Li, M.D., Ph.D.

  Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: May 31, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 27, 2015

Record last verified: 2015-01

Locations

CN (14)