RecruitingNot ApplicableNCT04710758

Multicenter Study on Laparoscopic Total Gastrectomy for Advanced Gastric Cancer

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

Sponsor

Shanghai Zhongshan Hospital

Enrollment

1,018 participants

Start Date

Jan 20, 2021

Study Type

INTERVENTIONAL

Conditions

Stomach Neoplasms

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This multicenter study is evaluating the safety and effectiveness of laparoscopic (minimally invasive) total gastrectomy (complete stomach removal) with thorough lymph node removal (D2 dissection) for patients with advanced gastric (stomach) cancer in the upper or middle part of the stomach. **You may be eligible if...** - You are between 18 and 75 years old - Your stomach cancer is located in the middle or upper third of the stomach - Your cancer has been confirmed by pathology and is at clinical stage T2-4a (without distant spread, N0-3) - Surgeons expect they can achieve a complete removal (curative resection) through total gastrectomy - Your general health and organ function are adequate **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have had prior stomach surgery - You have serious heart, lung, or other organ problems that make surgery unsafe - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELaparoscopic total gastrectomy

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

PROCEDUREOpen total gastrectomy

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

Locations(1)

ZhongShan hospital FuDan university

Shanghai, Shanghai Municipality, China

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NCT04710758

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