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

Recruiting

• Conditions: Gastric Cancer
• Interventions: Other: pre- or perioperative treatment and D2 gastrectomy

• Registration Number: NCT06472063
• Lead Sponsor: San Luigi Gonzaga Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-22
• Primary Completion: 2023-08-30
• Status Verified: 2024-06
• Study First Submitted: 2024-06-18
• Study First Submitted QC: 2024-06-23
• Last Update Submitted: 2024-06-23
• Study First Posted: 2024-06-24
• Last Update Posted: 2024-06-24
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 684

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pre- or perioperative treatment and D2 gastrectomy (NAC)	pre- or perioperative treatment and D2 gastrectomy	patients who underwent pre- or perioperative treatment and D2 gastrectomy

Primary Outcome Measures

Name	Time	Method
overall survival	3- and 5- year follow-up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

San Luigi University Hospital; 🇮🇹 Orbassano, Piedmont, Italy