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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04878783
• Other study ID #: URomLS2022
• Status: Active, not recruiting
• Start date: December 20, 2019
• Est. completion date: October 30, 2027

Study information

• Verified date: May 2024
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 138
• Est. completion date: October 30, 2027
• Est. primary completion date: October 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma of the Stomach
• Gastric Cancer
• Stomach Neoplasms

Intervention

Diagnostic Test:
• CT scan
Patients undergoing CT scan staging for gastric and EJ junction cancer + perioperative chemotherapy (FLOT regimen) , CT scan re-staging and radical gastrectomy or esophagogastrectomy will be enrolled in the study

Locations

Country	Name	City	State
Italy	University of Padova	Padova
Italy	Giovanni Maria Garbarino	Roma
Italy	Link Campus University	Roma
Italy	University of Verona	Verona
Netherlands	Amsterdam UMC location University of Amsterdam	Amsterdam	Nord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
University of Roma La Sapienza	Andrea Laghi

Countries where clinical trial is conducted

Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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