Upfront Surgery Versus NeoAdjuvant Chemotherapy Followed by Surgery for Resectable Advanced Gastric Cancer: SNAC Study

Summary

Based on the concerns about the actual low strength of evidence of the efficacy of NAC on survival of proper gastric cancer treated with adequate D2 gastrectomy as compared to the results of optimal upfront surgery (S), and considering the actual difficulties of additional RCTs, the aim of this study is to assess the non-inferiority of upfront surgery alone with optimal D2 dissection compared to NAC regimens followed by surgery. Methods: This is a nationwide Multicenter observational retrospective study with matched comparison of two therapeutic strategies (NAC vs S). We will include patients with cT\>2, every cN M0, or with every T and N+ M0, histologically proven adenocarcinoma of the stomach, submitted either to pre- or peri-operative treatment and D2 gastrectomy or to upfront D2 gastrectomy, between January 2012 and December 2019, followed by adjuvant treatment when recommended.

All patients matching the inclusion/exclusion criteria will be registered into the study and classified into one of the two arms: a, patients who underwent pre- or perioperative treatment and D2 gastrectomy (NAC) or b, patients submitted to upfront D2 gastrectomy (S). Given the results reported in the "FLOT" trial, a 3-years OS of 55% in the control arm (NAC) was assumed. Three-year OS in the experimental arm (S) was assumed to be 47.4% under the null hypothesis of inferiority and 55% under the alternative hypothesis of non-inferiority. A sample size of 684 patients (342 in each arm) achieves 80% power to detect a non-inferiority margin Hazard Ratio of 1.25

Conditions

• Gastric Cancer

Interventions

OTHER

pre- or perioperative treatment and D2 gastrectomy

pre- or perioperative treatment and D2 gastrectomy

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Senese

  collaborator OTHER

• IRCCS Ospedale San Raffaele

  collaborator OTHER

• Federico II University

  collaborator OTHER

• Azienda Ospedaliero-Universitaria di Parma

  collaborator OTHER

• Azienda Ospedaliero Universitaria Policlinico Modena

  collaborator OTHER

• Istituti Tumori Giovanni Paolo II

  collaborator NETWORK

• Fondazione IRCCS Policlinico San Matteo di Pavia

  collaborator OTHER

• ASST Grande Ospedale Metropolitano Niguarda

  collaborator OTHER

• Azienda Ospedaliera Sant'Anna

  collaborator OTHER

• Ospedale di Circolo - Fondazione Macchi

  collaborator OTHER

• Ospedale San Donato

  collaborator OTHER

• Government hospital in Forlì, Italy

  collaborator OTHER

• Istituti Ospitalieri di Cremona

  collaborator OTHER

• Azienda Ospedaliero-Universitaria Careggi

  collaborator OTHER

• Azienda ULSS di Verona e Provincia

  collaborator OTHER

• Azienda Ospedaliera di Perugia

  collaborator OTHER

• A.O. Ospedale Papa Giovanni XXIII

  collaborator OTHER

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

  collaborator OTHER

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  collaborator OTHER

• Provincia Autonoma di Trento

  collaborator OTHER_GOV

• University of Florence

  collaborator OTHER

• Ospedale M. Bufalini Cesena

  collaborator OTHER

• Azienda Ospedaliera di Padova

  collaborator OTHER

• Ospedale Guglielmo da Saliceto, Piacenza

  collaborator UNKNOWN

• Azienda Ospedaliera San Gerardo di Monza

  collaborator OTHER

• A.O.U. Città della Salute e della Scienza

  collaborator OTHER

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  collaborator OTHER

• Ospedale Santo Stefano

  collaborator OTHER

• Policlinico Abano Terme

  collaborator OTHER

• Istituto Europeo di Oncologia

  collaborator OTHER

• Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

  collaborator OTHER

• Humanitas Hospital, Italy

  collaborator OTHER

• San Luigi Gonzaga Hospital

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-22

Primary Completion

2023-08-30

Completion

2024-09-30

Countries

• Italy

Study Locations