Upfront Surgery Versus NeoAdjuvant Chemotherapy Followed by Surgery for Resectable Advanced Gastric Cancer (SNAC Study): An Observational Retrospective Multicenter Study With Matched Treatment Comparison

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 3.1.1. Locally advanced (T\>2 any N or N+ any T) histologically proven adenocarcinoma of the stomach without distant metastases (M0) and without infiltration of adjacent structures and organs.

• 1.2. D2 lymphadenectomy (based on Japanese gastric cancer guideline) 3.1.3. Age \> 18 years 3.1.4. surgical resectability 3.1.5. follow-up time of at least 36 months.

Locations
Other Locations
Italy
San Luigi University Hospital
RECRUITING
Orbassano
Contact Information
Primary
Rossella Reddavid, MD
rossella.reddavid@unito.it
+393479848651
Time Frame
Start Date: 2022-09-22
Estimated Completion Date: 2024-09-30
Participants
Target number of participants: 684
Treatments
upfront D2 gastrectomy (S)
patients submitted to upfront D2 gastrectomy
pre- or perioperative treatment and D2 gastrectomy (NAC)
patients who underwent pre- or perioperative treatment and D2 gastrectomy
Related Therapeutic Areas
Sponsors
Collaborators: Policlinico Abano Terme, A.O. Ospedale Papa Giovanni XXIII, Istituti Ospitalieri di Cremona, Federico II University, Azienda Ospedaliera Sant'Anna, Azienda Ospedaliera Universitaria Senese, Humanitas Hospital, Italy, Azienda Ospedaliera San Gerardo di Monza, IRCCS Ospedale San Raffaele, Azienda Ospedaliera di Padova, A.O.U. Città della Salute e della Scienza, ASST Grande Ospedale Metropolitano Niguarda, Azienda ULSS di Verona e Provincia, Government hospital in Forlì, Italy, University of Florence, Azienda Ospedaliero Universitaria Policlinico Modena, Istituto Europeo di Oncologia, Istituti Tumori Giovanni Paolo II, Ospedale M. Bufalini Cesena, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Fondazione IRCCS Policlinico San Matteo di Pavia, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, Azienda Ospedaliero-Universitaria di Parma, Ospedale di Circolo - Fondazione Macchi, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Azienda Ospedaliero-Universitaria Careggi, Ospedale Santo Stefano, Provincia Autonoma di Trento, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Azienda Ospedaliera di Perugia, Ospedale San Donato, Ospedale Guglielmo da Saliceto, Piacenza
Leads: San Luigi Gonzaga Hospital

This content was sourced from clinicaltrials.gov