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

• ClinicalTrials.gov Identifier: NCT01609309
• Recruitment Status: Unknown
• First Posted: May 31, 2012
• Last Update Posted: January 27, 2015
• Sponsor: Nanfang Hospital, Southern Medical University
• Information provided by (Responsible Party): Guoxin Li, Nanfang Hospital, Southern Medical University

Tracking Information

• First Submitted Date: May 29, 2012
• First Posted Date: May 31, 2012
• Last Update Posted Date: January 27, 2015
• Study Start Date: September 2012
• Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 29, 2012): 3-year disease free survival rate [ Time Frame: 36 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 29, 2014)

• Morbidity and mortality [ Time Frame: 30 days; 36 months ]
  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 ]
• 3-year recurrence pattern [ Time Frame: 36 months ]
  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 ]
  • Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recovery course.
  • The amount of abdominal drainage and blood transfusion are also recorded.
• Inflammatory and immune response [ Time Frame: 7 days ]
  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.

Original Secondary Outcome Measures (submitted: May 29, 2012)

• Morbidity and mortality [ Time Frame: 30 days; 36 months ]
  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 ]
• 3-year recurrence pattern [ Time Frame: 36 months ]
  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 ]
  • 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 ]
  The daily highest body temperature before discharge and the values of white blood cell count, hemoglobin, C-reactive protein, prealbumin and relevant immune cytokines from peripheral blood before operation and on postoperative day 1, 4, 7 are recorded.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Stomach Neoplasms

Intervention

• 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
• 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

Study Arms

• Experimental: Laparoscopic gastrectomy
  Laparoscopic distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
  Intervention: Procedure: Laparoscopic gastrectomy
• Active Comparator: Open gastrectomy
  Open distal subtotal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
  Intervention: Procedure: Open gastrectomy

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. doi: 10.1097/01.sla.0000151892.35922.f2.
• 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. Erratum In: N Engl J Med. 2008 May 1;358(18):1977.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 29, 2012): 1056
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2017
• Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 74 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01609309
• Other Study ID Numbers: CLASS - 01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Guoxin Li, Nanfang Hospital, Southern Medical University
• Original Responsible Party: Same as current
• Current Study Sponsor: Nanfang Hospital, Southern Medical University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Guoxin Li, M.D., Ph.D.; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China

• PRS Account: Nanfang Hospital, Southern Medical University
• Verification Date: January 2015