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CLASS-07: Multicenter Study on Laparoscopic Total Gastrectomy for Advanced Gastric Cancer

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04710758
Collaborator
(none)
1,316
Enrollment
1
Location
2
Arms
59.3
Anticipated Duration (Months)
22.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

CLASS-07 trial is a prospective, multicenter, randomized controlled trial for comparison of long-term outcomes between laparoscopic total gastrectomy (LTG) and open total gastrectomy (OTG) in patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0). The primary purpose of this study is to evaluate the overall survival and determine the efficacy of LTG compared with OTG for locally advanced gastric cancer. The second purpose is to evaluate the 3-year overall survival rate, 3-year disease free survival rate, morbidity and mortality rates, 3-year recurrence pattern and postoperative recovery course of the patients enrolled in this study.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopic total gastrectomy
  • Procedure: Open total gastrectomy
 N/A

Detailed Description

Gastric cancer is a significant global health problem, especially in East Asia. With an increase in the incidences of proximal gastric cancer over the last decades, the value of total gastrectomy is more emphasized. Laparoscopic total gastrectomy (LTG) has become an attracting option for surgeons due to its well-known advantages. However, more evidence is needed to support the safety and efficacy of LTG in locally advanced gastric cancer.

Recently，a multicenter, open-label, noninferiority, randomized clinical trial (CLASS-02) launched by Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group compared the safety of LTG for clinical stage I gastric cancer with open total gastrectomy (OTG). The overall morbidity and mortality rates were 19.1% in the LTG group and 20.2% in the OTG group, which was not significantly different (rate difference, -1.1%). This study demonstrated that LTG can be safely performed by experienced surgeons for clinical stage I gastric cancer. However, there hasn't been any prospective randomized clinical trial study evaluating the safety and efficacy of LTG in advanced gastric cancer.

This CLASS-07 trial is a prospective, multicenter, randomized controlled trial for comparison of long-term outcomes between LTG and OTG in patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0). The primary purpose of this study is to evaluate the overall survival and determine the efficacy of LTG compared with OTG for locally advanced gastric cancer. The second purpose is to evaluate the 3-year overall survival rate, 3-year disease free survival rate, morbidity and mortality rates, 3-year recurrence pattern and postoperative recovery course of the patients enrolled in this study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1316 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Randomized Controlled Multicenter Clinical Trial For Comparison Of Long-term Outcomes Between Laparoscopic And Open Total Gastrectomy In Patients With Locally Advanced Gastric Cancer
Actual Study Start Date :
Jan 20, 2021
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Laparoscopic total gastrectomy

The surgeon will perform LTG with D2 lymphadenectomy for patients enrolled in this group.

Procedure: Laparoscopic total gastrectomy
LTG with D2 lymphadenectomy for patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0)
Other Names:
  • Experimental group (LTG)

    		•
    Active Comparator: Open total gastrectomy

    The surgeon will perform OTG with D2 lymphadenectomy for patients enrolled in this group.

    Procedure: Open total gastrectomy
    OTG with D2 lymphadenectomy for patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0)
    Other Names:
  • Control group (OTG)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [3 years]

      Overall survival (OS) was defined as the time from randomization to death from any cause

    Secondary Outcome Measures

    1. 3-year overall survival rate [3 years]

      # of patients who are still alive at 3 years out of all study patients

    2. 3-year disease free survival rate [3 years]

      # of patients who are free of gastric cancer at 3 years out of all study patients

    3. Early morbidity rate [30 days]

      The early morbidity are defined as the event observed within 30 days following surgery, including intraoperative and postoperative complications

    4. Early mortality rate [30 days]

      The early mortality are defined as the event observed within 30 days following surgery, including intraoperative and postoperative death

    5. 3-year recurrence pattern [3 years]

      Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type

    6. Postoperative recovery course [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Aged 18-75 years

    2. Tumor located in the middle or upper third of the stomach, and curative resection is expected to be achievable by total gastrectomy with D2 lymphadenectomy (also apply to multiple primary cancers);

    3. 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;

    4. Clinical stage T2-4aN0-3M0 (According to AJCC-8th TNM staging system);

    5. Expected survival > 6 months

    6. No invasion to Z-line;

    7. BMI (Body Mass Index) < 30 kg/m2

    8. No history of upper abdominal surgery (except for laparoscopic cholecystectomy);

    9. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc

    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 regional fusion of enlarged lymph nodes (max diameter ≥ 3.0cm) or enlargment of spleen hilus lymph nodes

    2. Women during pregnancy or breast-feeding

    3. Synchronous or metachronous (within 5 years) malignancies

    4. Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated

    5. Severe mental disease

    6. Severe respiratory disease, FEV1 < 50% of predicted

    7. Severe hepatic and renal dysfunction

    8. Unstable angina pectoris or history of myocardial infarction within 6 months

    9. History of cerebral infarction or cerebral hemorrhage within 6 months

    10. Continuous systemic steroid therapy within 1 month (except for topical use)

    11. Gastric cancer complications (bleeding, perforation, obstruction) that requiring emergency surgery

    12. Patients are participating or have participated in another clinical trial (within 6 months)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ZhongShan hospital FuDan university Shanghai Shanghai China 200032

    Sponsors and Collaborators

    • Shanghai Zhongshan Hospital

    Investigators

    • Principal Investigator: Yihong Sun, MD, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Shanghai Zhongshan Hospital
    ClinicalTrials.gov Identifier:
    NCT04710758
    Other Study ID Numbers:
    • ZSGC-006
    First Posted:
    Jan 15, 2021
    Last Update Posted:
    Feb 25, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shanghai Zhongshan Hospital
    Stomach Neoplasms
    Laparoscopic total gastrectomy
    Open total gastrectomy
    Additional relevant MeSH terms:
    Stomach Neoplasms

    Study Results

    No Results Posted as of Feb 25, 2021