NCT06472063

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
684

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

11 months

First QC Date

June 18, 2024

Last Update Submit

June 23, 2024

Conditions

Gastric Cancer

Keywords

upfront surgeryperioperative treatmentD2 lymphadenectomy

Outcome Measures

Primary Outcomes (1)

  • overall survival

    3- and 5- year follow-up

Secondary Outcomes (5)

  • 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

Study Arms (2)

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

Other: pre- or perioperative treatment and D2 gastrectomy

Interventions

pre- or perioperative treatment and D2 gastrectomyOTHER

pre- or perioperative treatment and D2 gastrectomy

Also known as: perioperative treatment
pre- or perioperative treatment and D2 gastrectomy (NAC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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).

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Luigi University Hospital

Orbassano, Piedmont, 10043, Italy

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Lead

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsMetals

Central Study Contacts

Rossella Reddavid, MD

CONTACT

+393479848651rossella.reddavid@unito.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 18, 2024

First Posted

June 24, 2024

Study Start

September 22, 2022

Primary Completion

August 30, 2023

Study Completion

September 30, 2024

Last Updated

June 24, 2024

Record last verified: 2024-06

Locations

IT(1)