An observational study in Gastric Cancer, sponsored by San Luigi Gonzaga Hospital. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-24.
Sponsored by San Luigi Gonzaga Hospital · Observational
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
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's planned enrollment of 684 is above the median of 278 across 790 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →San Luigi Gonzaga Hospital is the lead sponsor of 20 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 (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. 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)
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients submitted to upfront D2 gastrectomy
patients who underwent pre- or perioperative treatment and D2 gastrectomy
Other: pre- or perioperative treatment and D2 gastrectomy
pre- or perioperative treatment and D2 gastrectomy
Also known as: perioperative treatment
overall survival
Time frame: 3- and 5- year follow-up
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
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Sep 2022 to primary completion in Aug 2023, 11 months.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
San Luigi Gonzaga Hospital