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Multicenter Study on Laparoscopic Total Gastrectomy for Advanced Gastric Cancer

ConditionStomach Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-75 years

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);

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;

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

Disqualifiers

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

Women during pregnancy or breast-feeding

Synchronous or metachronous (within 5 years) malignancies

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Laparoscopic total gastrectomy

    Procedure/Surgery

    LTG with D2 lymphadenectomy for patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0)

  • Open total gastrectomy

    Procedure/Surgery

    OTG with D2 lymphadenectomy for patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0)

Treatment groups

1,018 Participants
are divided into 2 treatment groups
Group A: Laparoscopic total gastrectomyExperimental treatment 1 intervention
Group B: Open total gastrectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

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

Time frame
3 years

Secondary outcomes

1

3-year overall survival rate

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

Time frame
3 years
2

3-year disease free survival rate

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

Time frame
3 years
3

Early morbidity rate

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

Time frame
30 days
4

Early mortality rate

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

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov
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