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Clinical Trials in Italy / NCT06923449
Recruiting Observational

Gastric Cancer' Textbook Oncological Outcome and Tumor Board Performance

NCT06923449 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Observational
Started
2024-05-16
Last updated
2025-04-11

Condition(s) studied

Stomach Neoplasm

Investigational drug(s) / intervention(s)

Multidisciplinary Tumor Board

Multidisciplinary Tumor Board: Institution of Multidisciplinary Tumor Board for Gastric Cancer at Fondazione Policlinico Gemelli in november 2019

Study summary

The goal of this observational, no-profit, spontaneous, retrospective, monocentric study is to compare surgical and oncologic outcomes in patients affected by gastric cancer before and after the institution of the Tumor Board, a multidisciplinary weekly case discussion. The main question it aims to answer is whether the Textbook Outcome (TO) and Textbook Oncological Outcome (TOO) of patients with non-early, non-metastatic gastric cancer undergoing surgical treatment with curative intent have improved before (from January 2018 to November 2019) and after (from December 2019 onwards) the establishment of the Multidisciplinary Tumor Board (MTB) at Fondazione Policlinico Gemelli (FPG).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * pathology-confirmed diagnosis of gastric adenocarcinoma * age 18 years or older * surgical candidates with curative intent Exclusion Criteria: * Endoscopic Mucosal Resection (EMR) or Endoscopic Submucosal Dissection (ESD) * previous EMR or ESD (salvage surgery) * histologies other than adenocarcinoma (no squamous cell carcinomas, GISTs, sarcomas, lymphomas, etc) * unsufficient staging (unclear clinical stage at diagnosis) * emergency presentation (obstrucetd, significantly bleeding, perforated gastric cancer) * synchronous tumors affecting survival * pregnant patients * age \<18years

Primary outcome measure(s)

  • Textbook Outcome (TO) — january 2018 - february 2024
    fulfillment of 10 items consisting in (1) radical resection according to the surgeons' assessment at the end of the operation, (2) no intraoperative complications, (3) negative resection margins (R0), (4) at least 15 lymph nodes (LNs) retrieved and examined, (5) no severe postoperative complications, (6) no reinterventions, (7) no readmission to intensive care unit (ICU), (8) no prolonged hospital stay (21 days), (9) no postoperative mortality, and (10) no hospital readmission
  • Textbook Oncologic Outcome (TOO) — january 2018 - february 2024
    TOO is defined by the addition of PeriOperative Chemotherapy (POC) or Adjuvant chemoTherapy (AT) administration to the 10 TO items resulting in 11 items

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome IT Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06923449 on ClinicalTrials.gov ↗ ← All trials in Italy