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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Siena

About this trial

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.

Eligibility criteria

Qualifiers

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

Mediastinal lymph nodes

Lung metastases

Disqualifiers

Contraindications for any sort of appropriate chemotherapy according to local standards

Linitis plastica

Second uncontrolled malignant tumour (synchronous or metachronous (last 5 years) other than Cis or mucosal cancer

Neoplasms involving the esophago-gastric junction (Siewert types I and II)

Trial design

Treatments tested in this trial

  • Gastrectomy with D2 lymphadenectomy
  • Gastrectomy with D2plus lymphadenectomy

Treatment groups

539 Participants
are divided into 2 treatment groups

Sponsors and collaborators