Radiomics and Molecular Expression Predictive Model for Esophago-Gastric Junction and Gastric Cancer TRG

CT Scan-Based Radiomics and Molecular Expression Predictive Model to Assess Tumor Regression Grade Following Perioperative Chemotherapy in Esophago-Gastric Junction and Gastric Cancer

The aim of this study is to develop a CT scan-based radiomics predictive model about tumor regression grade (TRG) in patients with esophago-gastric junction (EGJ) ang gastric cancer undergoing perioperative chemotherapy. The molecular expression of the neoplasms will be evaluated to assess its association with the TRG and the radiomic features.

Study Overview

• Status: Active, not recruiting
• Conditions: Gastric Cancer; Adenocarcinoma of the Stomach
• Intervention / Treatment: Diagnostic test: CT scan

Detailed Description

• To compare the radiomic features of the CT scans at the time of diagnosis (T0) and at the end of the preoperative chemotherapy (T1) in order to predict the TRG with the texture analysis on the first CT scan.

A non-good response (non-GR) has shown to be predictable with texture analysis on the pre-treatment CT scan.

Therefore, we hypothesize that texture analysis could let to identify the good response patients.

• To find correlation between the molecular expression of the tumor and the radiomics features.

Texture analysis on the pre-chemotherapy CT scan founded that entropy and compactness were higher and uniformity lower in responders. Nonetheless the association between radiomics features and molecular expression has not been investigated yet.

Therefore, we hypothesize to add some others radiomics signatures to the analysis and to find an association with the molecular expression.

• To find correlation between the molecular expression of the tumor and the TRG.

MSI gastric cancer has been shown to be less responsive to preoperative chemotherapy.

Therefore, we hypothesize to confirm this result.

• Study Type: Observational
• Enrollment (Actual): 138

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy, 35128
    • University of Padova
  • Roma, Italy, 00189
    • Giovanni Maria Garbarino
  • Roma, Italy, 00165
    • Link Campus University
  • Verona, Italy
    • University of Verona
• Netherlands
  • Nord-Holland
    • Amsterdam, Nord-Holland, Netherlands, 1081 HV
      • Amsterdam UMC location University of Amsterdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with cT2-T4a, cN0-N3, M0 gastric or EGJ cancer who undergo FLOT perioperative chemotherapy followed by radical surgical resection.

Description

Inclusion Criteria:

• Patients with histologically proven adenocarcinoma of the EGJ (Siewert II-III) or stomach.
• Preoperative staging: cT2-T4a, cN0-N3, M0.
• Patients >18 years old.
• Patients undergoing perioperative chemotherapy with Docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil (FLOT).

Exclusion Criteria:

• Siewert I EGJ tumor
• Patients undergoing preoperative radiotherapy.
• Absence of both pre and post-chemotherapy CT-scan.
• Patients with tumor progression during preoperative chemotherapy.
• Patients undergoing other neoadjuvant chemotherapy regimen different from FLOT
• Exploratory laparoscopy with positive cytology on the peritoneal lavage or evidence of peritoneal carcinosis

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive performance of radiomics analysis on the pre-treatment CT scan.	Comparing the radiomic features of the CT scans at the time of diagnosis (T0) and at the end of the preoperative chemotherapy (T1) in order to predict the TRG with the texture analysis on the first CT scan.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of the radiomics features with the molecular expression of the tumor.	Texture analysis on the pre-chemotherapy CT scan founded that entropy and compactness were higher and uniformity lower in responders. Nonetheless the association between radiomics features and molecular expression has not been investigated yet. Therefore, we hypothesize to add some others radiomics signatures to the analysis and to find an association with the molecular expression.	2 months
Evaluation of the association between TRG and the molecular expression of the tumor.	Investigate if the molecular expression of the tumor can influence the TRG	2 months
Association between radiomics and molecular expression in regards to long-term outcomes	Analysis of the 3 and 5y DFS and OS of patients with the radiomics and molecular expression profile	5 years

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Collaborators: Andrea Laghi

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2019
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 30, 2027

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: FLOT; gastric cancer; perioperative chemotherapy; radiomics; molecular expression; esophago-gastric junction cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: URomLS2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No