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

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: Stomach Neoplasm
• Intervention / Treatment: Other: Multidisciplinary Tumor Board

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

• Study Contact: Name: Laura Antolino, MD, PhD; Phone Number: +393470409876; Email: laura.antolino@gmail.com
• Study Contact Backup: Name: Cristina Vacca; Email: cristina.vacca@policlinicogemelli.it

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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)	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)	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)	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)	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)	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

• 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

General Publications

• Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
• Kim TH, Suh YS, Huh YJ, Son YG, Park JH, Yang JY, Kong SH, Ahn HS, Lee HJ, Slankamenac K, Clavien PA, Yang HK. The comprehensive complication index (CCI) is a more sensitive complication index than the conventional Clavien-Dindo classification in radical gastric cancer surgery. Gastric Cancer. 2018 Jan;21(1):171-181. doi: 10.1007/s10120-017-0728-3. Epub 2017 Jun 8.
• Busweiler LA, Schouwenburg MG, van Berge Henegouwen MI, Kolfschoten NE, de Jong PC, Rozema T, Wijnhoven BP, van Hillegersberg R, Wouters MW, van Sandick JW; Dutch Upper Gastrointestinal Cancer Audit (DUCA) group. Textbook outcome as a composite measure in oesophagogastric cancer surgery. Br J Surg. 2017 May;104(6):742-750. doi: 10.1002/bjs.10486. Epub 2017 Feb 27.
• Sedlak K, Rawicz-Pruszynski K, Mlak R, Geca K, Skorzewska M, Pelc Z, Malecka-Massalska T, Polkowski WP. Union is strength: Textbook outcome with perioperative chemotherapy compliance decreases the risk of death in advanced gastric cancer patients. Eur J Surg Oncol. 2022 Feb;48(2):356-361. doi: 10.1016/j.ejso.2021.08.005. Epub 2021 Aug 11.
• Sedlak K, Rawicz-Pruszynski K, Mlak R, Van Sandick J, Gisbertz S, Pera M, Dal Cero M, Baiocchi GL, Celotti A, Morgagni P, Vittimberga G, Hoelscher A, Moenig S, Kolodziejczyk P, Richter P, Gockel I, Piessen G, Da Costa PM, Davies A, Baker C, Allum W, Romario UF, De Pascale S, Rosati R, Reim D, Santos LL, D'ugo D, Wijnhoven B, Degiuli M, De Manzoni G, Kielan W, Frejlich E, Schneider P, Polkowski WP. Textbook Oncological Outcome in European GASTRODATA. Ann Surg. 2023 Nov 1;278(5):823-831. doi: 10.1097/SLA.0000000000006054. Epub 2023 Aug 9.
• Pillay B, Wootten AC, Crowe H, Corcoran N, Tran B, Bowden P, Crowe J, Costello AJ. The impact of multidisciplinary team meetings on patient assessment, management and outcomes in oncology settings: A systematic review of the literature. Cancer Treat Rev. 2016 Jan;42:56-72. doi: 10.1016/j.ctrv.2015.11.007. Epub 2015 Nov 24.
• Hanna TP, King WD, Thibodeau S, Jalink M, Paulin GA, Harvey-Jones E, O'Sullivan DE, Booth CM, Sullivan R, Aggarwal A. Mortality due to cancer treatment delay: systematic review and meta-analysis. BMJ. 2020 Nov 4;371:m4087. doi: 10.1136/bmj.m4087.
• Pak LM, Yang T, Wang J. The safety and efficacy of gastrectomy for gastric cancer among octogenarians: a western population-based study. J Geriatr Oncol. 2019 Jul;10(4):598-603. doi: 10.1016/j.jgo.2018.10.012. Epub 2018 Oct 24.

Study record dates

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: Gastric Cancer; Multidisciplinary Tumor Board; Textbook Outcome; Textbook Oncological Outcome
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• 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