Gastric CancerSNACNCT06472063
Upfront Surgery Versus NeoAdjuvant Chemotherapy Followed by Surgery for Resectable Advanced Gastric Cancer: SNAC Study
An observational study of Gastric Cancer, run by San Luigi Gonzaga Hospital at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- pre- or perioperative treatment and D2 gastrectomy
- How many people
- 684 participants
- Where
- 1 siteItaly
- Study dates
- 22 Sep 2022to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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)
- -
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Luigi University Hospital
Orbassano, Piedmont, 10043
About this 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
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
- Conditions
- Gastric Cancer
- Being tested
- pre- or perioperative treatment and D2 gastrectomy
- Keywords
- upfront surgery, perioperative treatment, D2 lymphadenectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre- or perioperative treatment and D2 gastrectomyOther
Also called perioperative treatment
pre- or perioperative treatment and D2 gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: pre- or perioperative treatment and D2 gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 3- and 5- year follow-up
Secondary outcomes (5)
disease free survival (DFS)
Measured: [ Time Frame: 2-year follow-up ]
Perioperative Morbidity and Mortality
Measured: Time Frame: up to 2 months after surgery
R0-Resection rate
Measured: 2 months after surgery
Rate of NAC patients submitted to surgery
Measured: 3 years
Rate of NAC patients completing postoperative treatment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start22 Sep 2022
- Primary completion30 Aug 2023
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 684 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Luigi Gonzaga Hospital
- Sponsor type
- University, hospital or 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
- Responsible party
- Principal investigator, Rossella Reddavid, San Luigi Gonzaga Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472063
- Sponsor's protocol ID
- SNAC01
- Acronym
- SNAC
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06472063
- Acronym / sponsor ID
- SNAC / SNAC01
- Conditions
- Gastric Cancer
- Keywords
- upfront surgery, perioperative treatment, D2 lymphadenectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 684 participants (estimated)
- Lead sponsor
- San Luigi Gonzaga HospitalUniversity, hospital or 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
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre- or perioperative treatment and D2 gastrectomyAlso: perioperative treatmentpre- or perioperative treatment and D2 gastrectomy | Other | pre- or perioperative treatment and D2 gastrectomy (NAC) |
Primary outcome
overall survival
Time frame: 3- and 5- year follow-up
5 secondary outcomes
disease free survival (DFS)
Time frame: [ Time Frame: 2-year follow-up ]
Perioperative Morbidity and Mortality
Time frame: Time Frame: up to 2 months after surgery
R0-Resection rate
Time frame: 2 months after surgery
Rate of NAC patients submitted to surgery
Time frame: 3 years
Rate of NAC patients completing postoperative treatment
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by San Luigi Gonzaga Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rossella Reddavid, MD (+393479848651, rossella.reddavid@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 3- and 5- year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.