Ignite Creation Date:
2024-07-17 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06472063
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-18
Brief Title:
Upfront Surgery Versus NeoAdjuvant Chemotherapy Followed by Surgery for Resectable Advanced Gastric Cancer SNAC Study
Sponsor:
San Luigi Gonzaga Hospital
Organization:
San Luigi Gonzaga Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SNAC
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 cT2 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 inclusionexclusion 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 474 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 125
All patients matching the inclusionexclusion 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 474 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 125
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None