Gastric Cancer' Textbook Oncological Outcome and Tumor Board Performance (GaC-TOP)

April 4, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Gastric Cancer' Textbook Oncological Outcome and Tumor Board Performance - The Experience of a High-volume Italian University Hospital

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background. Textbook Outcome (TO) is a composite parameter for quality in surgical oncology proposed by the Dutch Upper Gastrointestinal Cancer Audit (DUCA) group, directly related to survival [1]. A Polish group proposed an integration to the TO, adding the item perioperative chemotherapy administration compliance (POC), for a comprehensive assessment of multimodal treatment in gastric cancer (GaC) patients' management, named Textbook Oncological Outcome (TOO) [2]. This has been subsequently validated in the European GASTRODATA database [3], showing a correlation with lower 90-day mortality rates. The latter study acknowledges a TO of 68.5%, higher than previous experiences reported from the Western world, while reporting a TOO of only 22.8%, pointing out the need to improve multimodal treatment of GC patients.

To evaluate any influence of systematic Multidisciplinary Tumor Board (MTB) on patient outcomes, we aim to assess TO, TOO, Time from first diagnosis To first Therapy (TTT), the appropriateness of Patient to Treatment Allocation (PTA), and MTB hospital Adherence (TBA) as indicators of Tumor Board Performance (TBP) before and after its institution. At Policlinico Universitario Agostino Gemelli, the MTB for GaC was established in November 2019. We will collect data from 2018 to date in order to minimize bias due to different perioperative regimens.

Hypothesis. We hypothesize a global improvement in GaC patients' TO and TOO following the institution of the MTB.

Objectives. The study's primary objective is to evaluate the Textbook Outcome (TO) and Textbook Oncological Outcome (TOO) of patients with gastric cancer undergoing surgical treatment with curative intent 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) (primary endpoint: percentage of patients achieving TO and TOO out of the total number of patients who underwent surgery with curative intent for gastric cancer at FPG before and after the MTB institution). Secondary objectives include assessing Tumor Board Performance (TBP) by measuring: - Time from diagnosis To Treatment, the interval between diagnosis and beginning of the first oncological treatment (TTT; endpoint: delay in days/weeks from diagnosis to treatment before and after MTB institution), - Patient to Treatment Allocation (PTA; endpoint: percentage of upfront surgery candidates who do not receive adjuvant chemotherapy before and after MTB institution) and - Tumor Board Adherence (TBA; endpoint: percentage of patients operated on at FPG who were previously discussed at the MTB out of the total number of patients who underwent surgery with curative intent for gastric cancer at FPG).

Methods. We will review clinical, pathological, surgical and oncological data of patients affected by Gastric Cancer candidated for surgical intervention -either upfront, either post neoadjuvant treatment, either in conversion surgery- with curative intent for primary and secondary outcomes.

Expected results. This study aims to demonstrate an improvement in Gastric Cancer patients' outcomes, such as Textbook Outcome (TO) and Textbook Oncological Outcome (TOO), following the establishment of the MTB. Additionally, we anticipate enhanced Tumor Board Performance over time, thanks to the improvements of Time from Diagnosis to Treatment (TTT), Tumor Board Adherence (TBA), and Patient to Treatment Allocation (PTA), attributable to a learning effect.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • IT
      • Rome, IT, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-TB
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 jan 2018 to november 2019
Post-TB
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 december 2019 onwards
Other: Multidisciplinary Tumor Board
Institution of Multidisciplinary Tumor Board for Gastric Cancer at Fondazione Policlinico Gemelli in november 2019

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Textbook Outcome (TO)
Time Frame: 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
january 2018 - february 2024
Textbook Oncologic Outcome (TOO)
Time Frame: 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
january 2018 - february 2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time To first Treatment (TTT)
Time Frame: january 2018 - february 2024
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
january 2018 - february 2024
Patient to Treatment Allocation (PTA)
Time Frame: january 2018 - february 2024
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
january 2018 - february 2024
Tumor Board Adherence (TBA)
Time Frame: january 2018 - february 2024
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
january 2018 - february 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborators

Società Italiana di Chirurgia Oncologica SICO - ESSO affiliated

Investigators

  • Principal Investigator: Alberto Biondi, Prof., Fondazione Policlinico Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

April 4, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID 6671 Prot.n.0010178/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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