RADIOMICS AND MOLECULAR EXPRESSION PREDICTIVE MODEL FOR ESOPHAGO-GASTRIC JUNCTION AND GASTRIC CANCER TRG

Study Overview
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Brief Summary
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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.

Detailed Description
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• 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.

Official Title
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CT SCAN-BASED RADIOMICS AND MOLECULAR EXPRESSION PREDICTIVE MODEL TO ASSESS TUMOR REGRESSION GRADE FOLLOWING PERIOPERATIVE CHEMOTHERAPY IN ESOPHAGO-GASTRIC JUNCTION AND GASTRIC CANCER

Conditions
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Gastric Cancer, Adenocarcinoma of the Stomach

Intervention / Treatment
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* Diagnostic Test: CT scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiomics, molecular expression, perioperative chemotherapy, FLOT, gastric cancer, esophago-gastric junction cancer