Upfront Surgery Versus NeoAdjuvant Chemotherapy Followed by Surgery for Resectable Advanced Gastric Cancer: SNAC Study
NCT Number: NCT06472063
Acronym: SNAC
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastric Cancer
Interventions: OTHER: pre- or perioperative treatment and D2 gastrectomy
Sponsor: San Luigi Gonzaga Hospital
Collaborators: Azienda Ospedaliera Universitaria Senese|IRCCS Ospedale San Raffaele|Federico II University|Azienda Ospedaliero-Universitaria di Parma|Azienda Ospedaliero Universitaria Policlinico Modena|Istituti Tumori Giovanni Paolo II|Fondazione IRCCS Policlinico San Matteo di Pavia|ASST Grande Ospedale Metropolitano Niguarda|Azienda Ospedaliera, Ospedale Sant'Anna-Como|Ospedale di Circolo - Fondazione Macchi|Ospedale San Donato|Government hospital in Forlì, Italy|Istituti Ospitalieri di Cremona|Azienda Ospedaliero-Universitaria Careggi|Azienda ULSS di Verona e Provincia|Azienda Ospedaliera di Perugia|A.O. Ospedale Papa Giovanni XXIII|Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia|Fondazione Policlinico Universitario Agostino Gemelli IRCCS|Provincia Autonoma di Trento|University of Florence|Ospedale M. Bufalini Cesena|Azienda Ospedaliera di Padova|Ospedale Guglielmo da Saliceto, Piacenza|Azienda Ospedaliera San Gerardo di Monza|A.O.U. Città della Salute e della Scienza|Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico|Ospedale Santo Stefano|Policlinico Abano Terme|Istituto Europeo di Oncologia|Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona|Humanitas Hospital, Italy
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 684
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-22
Completion Date: 2024-09-30
Locations: San Luigi University Hospital, Orbassano, Piedmont, 10043, Italy

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

Primary Outcome Measures: overall survival, 3- and 5- year follow-up
Secondary Outcome Measures: disease free survival (DFS), [ Time Frame: 2-year follow-up ]|Perioperative Morbidity and Mortality, Time Frame: up to 2 months after surgery|R0-Resection rate, 2 months after surgery|Rate of NAC patients submitted to surgery, 3 years|Rate of NAC patients completing postoperative treatment, 3 years