Study On Safety Of Laparoscopic Total Gastrectomy For Clinical Stage I Gastric Cancer (CLASS02-01)

February 18, 2019 updated by: Yihong Sun, Shanghai Zhongshan Hospital

Prospective Randomized Controlled Multicenter Clinical Trial For Comparison Of Safety Between Laparoscopic And Open Total Gastrectomy In Patients With Clinical Stage I Gastric Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

227

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Laparoscopic total gastrectomy
The surgeon will perform LTG with D1+/D2-10 lymphadenectomy for patients enrolled in this group.
Procedure: Laparoscopic total gastrectomy
LTG with D1+/D2-10 lymphadenectomy for patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric adenocarcinoma
Other Names:
  • Study group (LTG)
OTHER: Open total gastrectomy
The surgeon will perform OTG with D1+/D2-10 lymphadenectomy for patients enrolled in this group.
Procedure: Open total gastrectomy
OTG with D1+/D2-10 lymphadenectomy for patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric adenocarcinoma
Other Names:
  • Control group (OTG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early operative morbidity and mortality rate
Time Frame: 30 days
The early operative morbidity and mortality are defined as the event observed within 30 days following surgery, including intraoperative and postoperative complications and/or death.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative hospital stay
Time Frame: 30 days
The length of postoperative hospital stay will be recorded.
30 days
Postoperative recovery course
Time Frame: 30 days
Time to first ambulation, flatus, liquid diet, and soft diet are used to assess the postoperative recovery course, which is a composite outcome measure.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 4, 2017

Primary Completion (ACTUAL)

October 24, 2018

Study Completion (ACTUAL)

October 24, 2018

Study Registration Dates

First Submitted

December 22, 2016

First Submitted That Met QC Criteria

December 30, 2016

First Posted (ESTIMATE)

January 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 18, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSGC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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