Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

University of Roma La Sapienza

Collaborating Sponsors:

Andrea Laghi

Conditions:

Gastric Cancer

Adenocarcinoma of the Stomach

Eligibility:

All Genders

18+ years

Brief 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 periope...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 20 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 30 2027

Estimated Enrollment :

138 Patients enrolled

Trial Details

Trial ID

NCT04878783

Start Date

December 20 2019

End Date

October 30 2027

Last Update

May 9 2024

Active Locations (5)

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Page 1 of 2 (5 locations)

1

University of Padova

Padua, Italy, 35128

2

Link Campus University

Roma, Italy, 00165

3

Giovanni Maria Garbarino

Roma, Italy, 00189

4

University of Verona

Verona, Italy