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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01609309
Other study ID # CLASS - 01
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received May 29, 2012
Last updated January 26, 2015
Start date September 2012
Est. completion date December 2017

Study information

Verified date January 2015
Source Nanfang Hospital of Southern Medical University
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1056
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 74 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


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.
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.

Locations

Country Name City State
China Peking University Cancer Hospital Beijing Beijing
China The People's Liberation Army General Hospital Beijing Beijing
China The Bethune First Hospital Jilin University Changchun Jilin
China West China Hospital, Sichuan University Chengdu Sichuan
China Fujian Medical University Union Hospital Fuzhou Fujian
China Fujian Provincial Cancer Hospital Fuzhou Fujian
China Nanfang Hospital, Southern Medical University Guangzhou Guangdong
China The Third Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong
China Harbin Medical University Cancer Hospital Harbin Heilongjiang
China Renji Hospital ,Shanghai Jiao Tong University School of Medicine Shanghai
China Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai
China Zhongshan Hospital, Fudan University Shanghai Shanghai
China Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
China Tangdu Hospital, the Fourth Military Medical University Xi'an Shanxi

Sponsors (1)

Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Erratum in: N Engl J Med. 2008 May 1;358(18):1977. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 3-year disease free survival rate 36 months No
Secondary Morbidity and mortality 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. 30 days; 36 months Yes
Secondary 3-year overall survival rate 36 months No
Secondary 3-year recurrence pattern Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type. 36 months No
Secondary Postoperative recovery course 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.
10 days No
Secondary Inflammatory and immune response 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-a from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded. 7 days No
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