NCT03961373

Standard Versus Super-extended Lymphadenectomy After Neo-adjuvant Chemotherapy for Gastric Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 539 (estimated)
• Sponsor: University of Siena · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In this study the patients with histological evidence of adenocarcinoma of the stomach will be screened and, if eligible, submitted to neo-adjuvant chemotherapy (NAC). After conclusions of NAC and obtaining informed consent, they will be registered and randomized to receive surgical D2 vs. D2plus lymphadenectomy.

Detailed description

This is a prospective multi-centre phase III, two-group, randomized and controlled trial designed to prove superiority of the experimental treatment arm (neo-adjuvant chemotherapy and super-extended lymphadenectomy). The trial population consists of patients who have histologically confirmed adenocarcinoma of the stomach with locally advanced primary tumour and no evidence of distant metastases (stage IIA-IIIC gastric cancer). The lymph node clinical metastases, before neo-adjuvant chemotherapy, must be limited to the first and second compartments (stations 1-12). STANDARD GROUP: Neoadjuvant chemotherapy + surgical gastrectomy with D2 lymphadenectomy. Patients who are assigned to neoadjuvant chemotherapy+ surgical D2 treatment group will undergo either subtotal or total gastrectomy, depending on the location of the primary tumour. Standardized D2-lymph node dissection is required with specific information about lymph node stations. EXPERIMENTAL GROUP: Neoadjuvant chemotherapy + surgical gastrectomy with D2plus lymphadenectomy. Patients who are assigned to neoadjuvant chemotherapy + surgical D2plus extended lymphadenectomy treatment group will undergo either subtotal or total gastrectomy, depending on the location of the primary tumour. Standardized D2 lymph node dissection plus resection of stations 8p, 12b/p, 13, 14v, 16a2/b1 is required with specific information about lymph node stations. In both groups, surgical treatment should be performed within 4-6 weeks after the end of the last cycle of NAC. The primary objective of this study is to compare overall and cancer-related survival between D2 and D2+ lymphadenectomy following neo-adjuvant chemotherapy for resectable gastric cancer. In addition, response to chemotherapy, resection rate, quality of life, complications attributable to surgical intervention / side effects of chemotherapy and the duration of hospitalization will be evaluated. Sample size estimation was performed, to detect the minimum number of patients to be recruited in each arm. A two-sided log rank test with an overall sample size of 539 subjects, of which 270 are in group 1 and 269 are in group 2. Data will be analyzed using SPSS software. Level of significance will be defined as 5%. The trial will be open for recruitment from October 2018 to September 2023.

Conditions

• Locally Advanced Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	Gastrectomy with D2 lymphadenectomy	Patients who are assigned to the neoadjuvant chemotherapy+ surgical D2 treatment group will undergo either subtotal or total gastrectomy, depending on the location of the primary tumour. Standardized D2-lymph node dissection is required with specific information about lymph node stations.
PROCEDURE	Gastrectomy with D2plus lymphadenectomy	Patients who are assigned to the neoadjuvant chemotherapy + surgical D2+ extended lymphadenectomy treatment group will undergo either subtotal or total gastrectomy, depending on the location of the primary tumour. Standardized D2+ lymph node dissection plus resection of stations 8p, 12p, 13, 14v, 16a2/b1 is required with specific information about lymph node stations.

Timeline

• Start date: 2018-11-05
• Primary completion: 2023-11-01
• Completion: 2028-11-01
• First posted: 2019-05-23
• Last updated: 2019-05-23

Locations

1 site across 1 country: Italy