Gastric Cancer' Textbook Oncological Outcome and Tumor Board Performance

NCT06923449 | Recruiting

• 1 other identifier: ID 6671 Prot.n.0010178/24
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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).

Conditions

Stomach Neoplasm

Keywords

Gastric Cancer; Multidisciplinary Tumor Board; Textbook Outcome; Textbook Oncological Outcome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Time To first Treatment (TTT)

  january 2018 - february 2024

• Patient to Treatment Allocation (PTA)

  january 2018 - february 2024

• Tumor Board Adherence (TBA)

  january 2018 - february 2024

Study Arms (2)

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

Interventions

Multidisciplinary Tumor Board OTHER

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

Post-TB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• pathology-confirmed diagnosis of gastric adenocarcinoma
• age 18 years or older
• surgical candidates with curative intent

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Società Italiana di Chirurgia Oncologica SICO - ESSO affiliated: collaborator

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, IT, 00168, Italy

RECRUITING

Related Publications (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.

  PMID: 28240357 BACKGROUND

• 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.

  PMID: 34404560 BACKGROUND

• 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.

  PMID: 37555342 BACKGROUND

• 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.

  PMID: 26643552 BACKGROUND

• 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.

  PMID: 33148535 BACKGROUND

• 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.

  PMID: 28597328 BACKGROUND

• 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.

  PMID: 3558716 BACKGROUND

• 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.

  PMID: 30366851 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Alberto Biondi, Prof.

  Fondazione Policlinico Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Antolino, MD, PhD

CONTACT

+393470409876; laura.antolino@gmail.com

Cristina Vacca

CONTACT

cristina.vacca@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: May 16, 2024
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)