Trials / Recruiting
RecruitingNCT04710758
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,018 (estimated)
- Sponsor
- Shanghai Zhongshan Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Laparoscopic total gastrectomy | LTG with D2 lymphadenectomy for patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0) |
| PROCEDURE | Open total gastrectomy | OTG with D2 lymphadenectomy for patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0) |
Timeline
- Start date
- 2021-01-20
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
- First posted
- 2021-01-15
- Last updated
- 2025-09-22
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04710758. Inclusion in this directory is not an endorsement.