Gastric Cancer' Textbook Oncological Outcome and Tumor Board Performance

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

pathology-confirmed diagnosis of gastric adenocarcinoma

age 18 years or older

surgical candidates with curative intent

Disqualifiers

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)

Trial population

All subsequent patients aged 18 years or older, surgical candidates with curative intent, with a pathology-confirmed diagnosis of gastric adenocarcinoma, treated at Fondazione Policlinico Universitario Agostino Gemelli IRCCS of Rome from 2018 to date.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Multidisciplinary Tumor Board

    Other intervention

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

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Pre-TB0 interventions
Group B: Post-TB1 intervention

Trial outcomes

Primary outcomes

1

Textbook Outcome (TO)

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

Time frame
january 2018 - february 2024
2

Textbook Oncologic Outcome (TOO)

TOO is defined by the addition of PeriOperative Chemotherapy (POC) or Adjuvant chemoTherapy (AT) administration to the 10 TO items resulting in 11 items

Time frame
january 2018 - february 2024

Secondary outcomes

1

Time To first Treatment (TTT)

TTT is defined as the interval from diagnosis to first treatment (first chemotherapy administration or radical surgery), the diagnosis will be traced to the date of final pathology of endoscopic biopsies; TTT will be subdivided in Staging Time (ST), time from first histology to completion of staging, and Waiting list Time (WT), time from last staging exam to first treatment

Time frame
january 2018 - february 2024
2

Patient to Treatment Allocation (PTA)

PTA appropriateness, indicated by the percentage of newly diagnosed patients undergoing upfront surgery who are not offered adjuvant therapy. This may be due to either early staging or because the patient is deemed unfit for systemic treatment. PTA will be calculated in patients aged 80y or younger, given that older patients less frequently receive neoadjuvant chemotherapy

Time frame
january 2018 - february 2024
3

Tumor Board Adherence (TBA)

TBA expressed as the percentage of patients who undergo surgery for Gastric Cancer at FPG after being discussed at the MTB over the totality of patients surgically treated for GaC at FPG

Time frame
january 2018 - february 2024

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Società Italiana di Chirurgia Oncologica SICO - ESSO affiliated

Collaborator