Using Radiomics to Predict Neoadjuvant Chemotherapy Efficacy

Completed

• Conditions: Gastric Cancer
• Interventions: Other: response to neoadjuvant chemotherapy

• Registration Number: NCT05465512
• Lead Sponsor: Fujian Medical University

Brief Summary

Neoadjuvant chemotherapy (NC) is an important treatment for advanced gastric cancer (AGC). However, tools that effectively predict the efficacy of NC before treatment are lacking. Computed tomography images before and after NC were used to construct a deep learning-based radiomics signature to predict the efficacy of NC, prognoses and postoperative adjuvant chemotherapy benefit.

Detailed Description

Background: Neoadjuvant chemotherapy (NC) is an important treatment for advanced gastric cancer (AGC). However, tools that effectively predict the efficacy of NC before treatment are lacking.

Methods: Computed tomography images before and after NC were used to construct a deep learning-based radiomics signature to predict the efficacy of NC, prognoses and postoperative adjuvant chemotherapy benefit. Tumor regression grade (TRG) =0 or 1 was defined as a good response to neoadjuvant chemotherapy (GRNC), and TRG=2 or 3 was defined as a poor response to neoadjuvant chemotherapy (PRNC). 193 patients with AGC from January 2010 to December 2018 in two different China university hospitals were included in this study. The before neoadjuvant chemotherapy imaging scoring system (BNCISS), imaging change scoring system before and after neoadjuvant chemotherapy (ICSS), which were constructed based on computed tomography images before after treatment.

Study Timeline

• Study Start: 2022-01-04
• Primary Completion: 2022-06-01
• Status Verified: 2022-07
• Study Completion: 2022-07-10
• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2022-07-15
• Last Update Submitted: 2022-07-15
• Study First Posted: 2022-07-19
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

Inclusion Criteria

• Prospective collection and a retrospective analysis of patients seen from January 2010 to December 2018 at Fujian Medical University Union Hospital (FMUUH) and the First Hospital of Lanzhou University (FHLU) who were diagnosed with gastric adenocarcinoma and underwent radical resection

Exclusion Criteria

• Patients with concurrent malignant disease, distant metastases, palliative resection, or gastric stump cancer were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
good response to neoadjuvant chemotherapy (GRNC)	response to neoadjuvant chemotherapy	Tumor regression grade (TRG) =0 or 1 was defined as a good response to neoadjuvant chemotherapy (GRNC)
poor response to neoadjuvant chemotherapy (PRNC)	response to neoadjuvant chemotherapy	TRG=2 or 3 was defined as a poor response to neoadjuvant chemotherapy (PRNC).

Primary Outcome Measures

Name	Time	Method
AUC for ICSS	2022-01-01 to 2022-07-31	The predictive performance of imaging change scoring system before and after neoadjuvant chemotherapy (ICSS)
AUC for BNCISS	2022-01-01 to 2022-07-31	The predictive performance of before neoadjuvant chemotherapy imaging scoring system (BNCISS)

Secondary Outcome Measures

Name	Time	Method
overall survival	2010-01-01 to 2022-07-31	3 year overall survival
disease free survival	2010-01-01 to 2022-07-31	3 year disease free survival

Trial Locations

Locations (1)

Department of Gastric Surgery; 🇨🇳 Fuzhou, Fujian, China