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

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ClinicalTrials.gov Identifier: NCT04710758
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Study Description
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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
Stomach Neoplasms Procedure: Laparoscopic total gastrectomy Procedure: Open total gastrectomy Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 20, 2021
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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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 Name: 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 Name: Control group (OTG)


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 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 [ Time Frame: 3 years ]
    # of patients who are still alive at 3 years out of all study patients

  2. 3-year disease free survival rate [ Time Frame: 3 years ]
    # of patients who are free of gastric cancer at 3 years out of all study patients

  3. Early morbidity rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

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): NCT04710758


Contacts
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Contact: Yihong Sun, MD 86-21-64041990 sun.yihong@zs-hospital.sh.cn

Locations
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China, Shanghai
ZhongShan hospital FuDan university Recruiting
Shanghai, Shanghai, China, 200032
Contact: Yihong Sun, MD    86-13701735406    sun.yihong@zs-hospital.sh.cn   
Principal Investigator: Yihong Sun, MD         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Principal Investigator: Yihong Sun, MD Fudan University
More Information
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Publications:

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04710758    
Other Study ID Numbers: ZSGC-006
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Stomach Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases