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

This study is ongoing, but not recruiting participants.
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: January 26, 2015
Last verified: January 2015
  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 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.

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 recovery 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: December 2017
Estimated Primary Completion Date: December 2017 (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

Locations
China, Beijing
Peking University Cancer Hospital
Beijing, Beijing, China, 100-142
The People's Liberation Army General Hospital
Beijing, Beijing, China, 100-853
China, Fujian
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350-001
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China, 350-014
China, Guangdong
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510-515
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510-630
China, Heilongjiang
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150-081
China, Hubei
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
China, Jilin
The Bethune First Hospital Jilin University
Changchun, Jilin, China, 130021
China, Shanghai
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200-025
Zhongshan Hospital, Fudan University
Shanghai, Shanghai, China, 200-032
China, Shanxi
Tangdu Hospital, the Fourth Military Medical University
Xi'an, Shanxi, China, 710-038
China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610-041
China
Renji Hospital ,Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200-127
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
Principal Investigator: Guoxin Li, M.D., Ph.D. Chinese Laparoscopic Gastrointestinal Surgery 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: January 26, 2015
Health Authority: China: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 29, 2015