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

NCT06472063 — Unknown, 684 participants, San Luigi Gonzaga Hospital
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Upfront Surgery Versus NeoAdjuvant Chemotherapy Followed by Surgery for Resectable Advanced Gastric Cancer (SNAC Study): An Observational Retrospective Multicenter Study With Matched Treatment Comparison

RegistryNCT06472063, acronym SNAC
StatusUnknown
Study typeObservational
Enrollment684 (Estimated)
SponsorSan Luigi Gonzaga Hospital (Other); 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 Sant'Anna, 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
ConditionsGastric Cancer
Interventionspre- or perioperative treatment and D2 gastrectomy (Other)
Datesstart 2022-09-22, primary completion 2023-08-30, completion 2024-09-30 (estimated), first posted 2024-06-24, last updated 2024-06-24
Locations1 site in Italy

Related Papers Related Patents Related Grants Related Experts
All trials for Gastric Cancer All trials of pre- or perioperative treatment and D2 gastrectomy

-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

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+Arms and interventions

ArmTypeInterventionsDescription
upfront D2 gastrectomy (S)patients submitted to upfront D2 gastrectomy
pre- or perioperative treatment and D2 gastrectomy (NAC)Other: pre- or perioperative treatment and D2 gastrectomypatients who underwent pre- or perioperative treatment and D2 gastrectomy
  • pre- or perioperative treatment and D2 gastrectomy (Other), also known as perioperative treatment: pre- or perioperative treatment and D2 gastrectomy

+Outcome measures

Primary outcomes

  • overall survival [3- and 5- year follow-up]

Secondary outcomes

  • 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]

+Eligibility

Sex: All, ages: 18 Years to any

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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+Locations (1)

FacilityCityCountryStatus
San Luigi University HospitalOrbassano, PiedmontItalyRecruiting