An observational study in Gastric Cancer and Adenocarcinoma of the Stomach, sponsored by University of Roma La Sapienza. Active, not recruiting at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by University of Roma La Sapienza · Observational
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.
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.
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.
MSI gastric cancer has been shown to be less responsive to preoperative chemotherapy.
Therefore, we hypothesize to confirm this result.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 138 is below the median of 274 across 670 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.
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Patients with cT2-T4a, cN0-N3, M0 gastric or EGJ cancer who undergo FLOT perioperative chemotherapy followed by radical surgical resection.
Exclusion Criteria:
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
Also known as: FLOT chemotherapy, Radical Gastrectomy with D2 Lymphadenectomy, Radical Esophagogastrectomy with D2 Lymphadenectomy
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.
Time frame: 2 months
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.
Time frame: 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
Time frame: 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
Time frame: 5 years
Plan to share: Undecided
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This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of Roma La Sapienza