Standard Versus Super-extended Lymphadenectomy After Neo-adjuvant Chemotherapy for Gastric Cancer
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.
• Age equal or greater than 18 years
• IIA-IIIC histologically proven primary gastric adenocarcinoma, before the treatment with NAC. Not including gastro-oesophageal junction/cardia carcinoma but only Siewert 3, without any previous treatment (surgery and / or chemotherapy) for this diagnosis
• Lack in CT scan of following:
‣ Mediastinal lymph nodes
⁃ Lung metastases
⁃ Peritoneal metastases
⁃ Liver metastases
⁃ Pleural effusion, ascites
⁃ Metastases to para-aortic lymph nodes No 16a2/b1
⁃ Metastases to lymph nodes located in the posterior area (8p, 12 b/p, 13)
⁃ Extra-regional lymph node metastases
• ECOG performance status ≤ 2
• No prior radio- or chemotherapy conflicting with the treatment of gastric cancer
• No oesophageal invasion, or invasion \<=3cm
• Negative peritoneal washing cytology findings and no peritoneal metastases in staging laparoscopy
• No gastric stump cancer
• No signs of cervical and subclavear lymph nodes or distal metastases
• Patient's consent form obtained, signed and dated before beginning specific protocol procedures
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial