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
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
Treatments tested in this trial
- Laparoscopic total gastrectomy
- Open total gastrectomy
Treatment groups
1,018 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov