Clinical trial NCT06472063: Upfront Surgery Versus NeoAdjuvant Chemotherapy Followed by Surgery for Resectable Advanced Gastric Cancer: SNAC Study
Official title: Upfront Surgery Versus NeoAdjuvant Chemotherapy Followed by Surgery for Resectable Advanced Gastric Cancer (SNAC Study): An Observational Retrospective Multicenter Study With Matched Treatment Comparison
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Keywords: upfront surgery
perioperative treatment
D2 lymphadenectomy
Lead sponsor: San Luigi Gonzaga Hospital
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Universitaria Senese
name: IRCCS Ospedale San Raffaele
name: Federico II University
name: Azienda Ospedaliero-Universitaria di Parma
name: Azienda Ospedaliero Universitaria Policlinico Modena
name: Istituti Tumori Giovanni Paolo II
name: Fondazione IRCCS Policlinico San Matteo di Pavia
name: ASST Grande Ospedale Metropolitano Niguarda
name: Azienda Ospedaliera, Ospedale Sant'Anna-Como
name: Ospedale di Circolo - Fondazione Macchi
name: Ospedale San Donato
name: Government hospital in Forlì, Italy
name: Istituti Ospitalieri di Cremona
name: Azienda Ospedaliero-Universitaria Careggi
name: Azienda ULSS di Verona e Provincia
name: Azienda Ospedaliera di Perugia
name: A.O. Ospedale Papa Giovanni XXIII
name: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Provincia Autonoma di Trento
name: University of Florence
name: Ospedale M. Bufalini Cesena
name: Azienda Ospedaliera di Padova
name: Ospedale Guglielmo da Saliceto, Piacenza
name: Azienda Ospedaliera San Gerardo di Monza
name: A.O.U. Città della Salute e della Scienza
name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Ospedale Santo Stefano
name: Policlinico Abano Terme
name: Istituto Europeo di Oncologia
name: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
name: Humanitas Hospital, Italy
First posted: 2024-06-24
Enrollment: 684
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 4.1.1. This is a nationwide Multicenter observational retrospective study with matched comparison of two therapeutic strategies (NAC vs upfront surgery). Participating centers should have a hospital volume of at least 20 gastric resections for stomach cancer per year. We will include a) patients with cT\>2, every cN, or b) patients with every T and N+, histologically proven adenocarcinoma of the stomach without distant metastases (M0) and without involvement of adjacent structures/organs, 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 who meet the inclusion/exclusion criteria will be registered into the study and classified to one of the two arms based on their treatment (a. Patients who underwent pre- or perioperative treatment and D2 gastrectomy - NAC or b. Patients submitted to upfront D2 gastrectomy- S).

Brief 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


Eligibility criteria: Inclusion Criteria:

* 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.

3.1.2. 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.

Exclusion Criteria:

3.2.1. distant metastases (cM+) or infiltration of adjacent structures or organs (cT4b) and all primarily not resectable stages 3.2.2. Other types of lymphadenectomy lower than D2 3.2.3. Siewert type I and II Cardia cancers 3.2.2. Relapsed gastric cancers 3.2.3. malignant secondary disease, dated back \< 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma)

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Primary outcomes:
measure: overall survival
timeFrame: 3- and 5- year follow-up
Secondary outcomes:
measure: disease free survival (DFS)
timeFrame: [ Time Frame: 2-year follow-up ]
measure: Perioperative Morbidity and Mortality
timeFrame: Time Frame: up to 2 months after surgery
measure: R0-Resection rate
timeFrame: 2 months after surgery
measure: Rate of NAC patients submitted to surgery
timeFrame: 3 years
measure: Rate of NAC patients completing postoperative treatment
timeFrame: 3 years
Other outcomes:
Locations:
city: Orbassano
country: Italy
facility: San Luigi University Hospital
state: Piedmont
Study officials:
References: