Multicenter Study on Laparoscopic Distal Subtotal Gastrectomy for Advanced Gastric Cancer (CLASS-01)
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|ClinicalTrials.gov Identifier: NCT01609309|
Recruitment Status : Unknown
Verified January 2015 by Guoxin Li, Nanfang Hospital of Southern Medical University.
Recruitment status was: Active, not recruiting
First Posted : May 31, 2012
Last Update Posted : January 27, 2015
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- 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 or disease||Intervention/treatment||Phase|
|Stomach Neoplasms||Procedure: Laparoscopic gastrectomy Procedure: Open gastrectomy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1056 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
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
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
Other Name: ODG
- 3-year disease free survival rate [ Time Frame: 36 months ]
- 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.
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|Ages Eligible for Study:||19 Years to 74 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609309
|Peking University Cancer Hospital|
|Beijing, Beijing, China, 100-142|
|The People's Liberation Army General Hospital|
|Beijing, Beijing, China, 100-853|
|Fujian Medical University Union Hospital|
|Fuzhou, Fujian, China, 350-001|
|Fujian Provincial Cancer Hospital|
|Fuzhou, Fujian, China, 350-014|
|Nanfang Hospital, Southern Medical University|
|Guangzhou, Guangdong, China, 510-515|
|The Third Affiliated Hospital of Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510-630|
|Harbin Medical University Cancer Hospital|
|Harbin, Heilongjiang, China, 150-081|
|Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology|
|Wuhan, Hubei, China, 430022|
|The Bethune First Hospital Jilin University|
|Changchun, Jilin, China, 130021|
|Ruijin Hospital, Shanghai Jiao Tong University School of Medicine|
|Shanghai, Shanghai, China, 200-025|
|Zhongshan Hospital, Fudan University|
|Shanghai, Shanghai, China, 200-032|
|Tangdu Hospital, the Fourth Military Medical University|
|Xi'an, Shanxi, China, 710-038|
|West China Hospital, Sichuan University|
|Chengdu, Sichuan, China, 610-041|
|Renji Hospital ，Shanghai Jiao Tong University School of Medicine|
|Shanghai, China, 200-127|
|Principal Investigator:||Guoxin Li, M.D., Ph.D.||Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Guoxin Li, M.D., Ph.D., Nanfang Hospital of Southern Medical University|
|Other Study ID Numbers:||
CLASS - 01
|First Posted:||May 31, 2012 Key Record Dates|
|Last Update Posted:||January 27, 2015|
|Last Verified:||January 2015|
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases