Clinical trial NCT04878783: Radiomics and Molecular Expression Predictive Model for Esophago-Gastric Junction and Gastric Cancer TRG
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gastric Cancer
Adenocarcinoma of the Stomach
Keywords: radiomics
molecular expression
perioperative chemotherapy
FLOT
gastric cancer
esophago-gastric junction cancer
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
Collaborators: name: Andrea Laghi
First posted: 2021-05-07
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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 perioperative chemotherapy. The molecular expression of the neoplasms will be evaluated to assess its association with the TRG and the radiomic features.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Predictive performance of radiomics analysis on the pre-treatment CT scan.
timeFrame: 2 months
Secondary outcomes:
measure: Association of the radiomics features with the molecular expression of the tumor.
timeFrame: 2 months
measure: Evaluation of the association between TRG and the molecular expression of the tumor.
timeFrame: 2 months
measure: Association between radiomics and molecular expression in regards to long-term outcomes
timeFrame: 5 years
Other outcomes:
Locations:
city: Padova
country: Italy
facility: University of Padova
city: Roma
country: Italy
facility: Link Campus University
city: Roma
country: Italy
facility: Giovanni Maria Garbarino
city: Verona
country: Italy
facility: University of Verona
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC location University of Amsterdam
state: Nord-Holland
Study officials:
References: