Upfront Surgery Versus NeoAdjuvant Chemotherapy Followed by Surgery for Resectable Advanced Gastric Cancer (SNAC Study): An Observational Retrospective Multicenter Study With Matched Treatment Comparison
Upfront Surgery Versus NeoAdjuvant Chemotherapy Followed by Surgery for Resectable Advanced Gastric Cancer: SNAC Study
Sponsors
Lead Sponsor
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
, 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 Source
San Luigi Gonzaga Hospital
Oversight Info
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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
Overall Status
Recruiting
Start Date
2022-09-22
Completion Date
2024-09-30
Primary Completion Date
2023-08-30
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
overall survival |
3- and 5- year follow-up |
Secondary Outcome
Measure |
Time Frame |
|
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 |
Number Of Groups
2
Enrollment
684
Condition
Intervention
Intervention Type
Other
Intervention Name
Description
pre- or perioperative treatment and D2 gastrectomy
Arm Group Label
pre- or perioperative treatment and D2 gastrectomy (NAC)
Other Name
perioperative treatment
Eligibility
Study Pop
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).
Sampling Method
Probability Sample
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)
-
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Contact
Last Name
Rossella Reddavid, MD
Phone
+393479848651
rossella.reddavid@unito.it
Location
Facility |
Status |
|
San Luigi University Hospital Orbassano 3171986 Piedmont 3170831 10043 Italy |
Recruiting |
Location Countries
Country
Italy
Verification Date
2024-06-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
San Luigi Gonzaga Hospital
Investigator Full Name
Rossella Reddavid
Investigator Title
MD, PhD
Keywords
Has Expanded Access
No
Condition Browse
Intervention Browse
Mesh Term
Lead
Arm Group
Arm Group Label
upfront D2 gastrectomy (S)
Description
patients submitted to upfront D2 gastrectomy
Arm Group Label
pre- or perioperative treatment and D2 gastrectomy (NAC)
Description
patients who underwent pre- or perioperative treatment and D2 gastrectomy
Firstreceived Results Date
N/A
Acronym
SNAC
Patient Data
Sharing Ipd
Undecided
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Other
Time Perspective
Retrospective
Study First Submitted
June 18, 2024
Study First Submitted Qc
June 23, 2024
Study First Posted
June 24, 2024
Last Update Submitted
June 23, 2024
Last Update Submitted Qc
June 23, 2024
Last Update Posted
June 24, 2024
ClinicalTrials.gov processed this data on November 26, 2025
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.