Gastric Cancer' Textbook Oncological Outcome and Tumor Board Performance

Recruiting

• Conditions: Stomach Neoplasm

• Registration Number: NCT06923449
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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).

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 Timeline

• Study Start: 2024-05-16
• Status Verified: 2025-04
• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Time To first Treatment (TTT)	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
Patient to Treatment Allocation (PTA)	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
Tumor Board Adherence (TBA)	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

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, IT, Italy