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NCT Number: NCT04878783

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Padova, Padova, Italy

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About this study

  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT Scan

Diagnostic Test

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

Other names: FLOT chemotherapy, Radical Gastrectomy with D2 Lymphadenectomy, Radical Esophagogastrectomy with D2 Lymphadenectomy

Primary outcomes

  1. Predictive performance of radiomics analysis on the pre-treatment CT scan.

    Time frame: 2 months

    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.

Secondary outcomes

  1. Association of the radiomics features with the molecular expression of the tumor.

    Time frame: 2 months

    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. Evaluation of the association between TRG and the molecular expression of the tumor.

    Time frame: 2 months

    Investigate if the molecular expression of the tumor can influence the TRG

  3. Association between radiomics and molecular expression in regards to long-term outcomes

    Time frame: 5 years

    Analysis of the 3 and 5y DFS and OS of patients with the radiomics and molecular expression profile

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Collaborators

  • Andrea Laghi

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2024
Study completion
2027
First posted
May 7, 2021
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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