Clinical trial NCT03007550: Study On Safety Of Laparoscopic Total Gastrectomy For Clinical Stage I Gastric Cancer
Official title: Prospective Randomized Controlled Multicenter Clinical Trial For Comparison Of Safety Between Laparoscopic And Open Total Gastrectomy In Patients With Clinical Stage I Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Keywords: Gastric cancer
Laparoscopic total gastrectomy
Open total gastrectomy
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This CLASS02-01 trial is a prospective, multicenter trial for laparoscopic total gastrectomy (LTG) and open total gastrectomy (OTG) in patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric cancer. The primary purpose of this study is to evaluate the early operative morbidity and mortality and determine the safety of LTG compared with OTG for clinical stage I gastric adenocarcinoma. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study.

Detailed description: Gastric cancer is an important health problem, being the fourth most common cancer and the third leading cause of cancer-related death worldwide. Age standardized mortality rates for gastric cancer are 14.3 per 100 000 in men and 6.9 per 100 000 in women. Incidence shows clear regional and sex variations-rates are highest in Eastern Asia, Eastern Europe, and South America and lowest in Northern and Southern Africa. More than 679 000 new cases and 498,000 deaths occur every year in China, and an increasing trend of proximal gastric cancer is observed during the past years.

More than 20 years after the introduction of laparoscopic gastrectomy, many large-scale randomized controlled trials have been conducted in Japan (JCOG0912 and JLSSG0901), Korea (KLASS01 and KLASS02), and China (CLASS01). These trials are all designed to evaluate the non-inferiority of laparoscopic-assisted distal gastrectomy (LADG) to its open counterpart. No RCT for laparoscopic total gastrectomy (LTG) exists at this moment. The standardization of techniques for esophagojejunal anastomosis in LTG has been difficult even for experienced surgeons.

At present, Japan (JCOG1401), Korea (KLASS03), and Netherlands (STOMACH) have planned or launched clinical studies on LTG. China is one of the countries with the highest incidence of gastric cancer and surgeons have accumulated extensive experience through CLASS01 study. So, it's time for conducting the clinical research on the safety of LTG for gastric cancer.

This CLASS02-01 trial is a prospective, multicenter trial for LTG and open total gastrectomy (OTG) in patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric cancer. The primary purpose of this study is to evaluate the early operative morbidity and mortality and determine the safety of LTG compared with OTG for clinical stage I gastric adenocarcinoma. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study.

Eligibility criteria: Inclusion Criteria:

1. Aged 18-75 years；
2. Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma;
3. Clinical stage IA (T1N0M0) or IB (T1N1M0, T2N0M0) (According to AJCC-7th TNM staging system);
4. Tumor located in the upper or middle third of the stomach, and curative resection is expected to be achievable by total gastrectomy with D1+/D2-10 lymphadenectomy (also apply to multiple primary cancers);
5. No invasion to Z-line;
6. BMI (Body Mass Index) \< 30 kg/m2;
7. No history of upper abdominal surgery (except for laparoscopic cholecystectomy);
8. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.;
9. No enlargement of splenic hilar lymph nodes;
10. Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1;
11. Preoperative ASA (American Society of Anesthesiologists) scoring: I-III;
12. Sufficient organ functions;
13. Written informed consent.

Exclusion Criteria:

1. Preoperative examinations indicate that the stage of the disease is stage II/III/IV;
2. Preoperative examination indicate enlargement of perigastric or retroperitoneal lymph nodes (min diameter≥1.0cm);
3. Women during pregnancy or breast-feeding;
4. Synchronous or metachronous (within 5 years) malignancies;
5. Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated;
6. Severe mental disease;
7. Severe respiratory disease;
8. Severe hepatic and renal dysfunction;
9. Unstable angina pectoris or history of myocardial infarction within 6 months;
10. History of cerebral infarction or cerebral hemorrhage within 6 months;
11. Continuous systemic steroid therapy within 1 month (except for topical use);
12. Gastric cancer complications (bleeding, perforation, obstruction) that requiring emergency surgery;
13. Patients are participating or have participated in another clinical trial (within 6 months).

Primary outcomes:
measure: Early operative morbidity and mortality rate
timeFrame: 30 days
Secondary outcomes:
measure: Postoperative recovery course
timeFrame: 30 days
measure: Postoperative hospital stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: ZhongShan hospital FuDan university
state: Shanghai
Study officials:
affiliation: Fudan University
name: Yihong Sun, MD
role: PRINCIPAL_INVESTIGATOR
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