Using Radiomics to Predict Neoadjuvant Chemotherapy Efficacy

Gastric Cancer Clinical Trial

Official title:

Using Radiomics to Predict Neoadjuvant Chemotherapy Efficacy and Postoperative Adjuvant Chemotherapy Benefit in Advanced Gastric Cancer: a Two-center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05465512
• Other study ID #: FMUUH-001
• Status: Completed
• Start date: January 4, 2022
• Est. completion date: July 10, 2022

Study information

• Verified date: July 2022
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: July 10, 2022
• Est. primary completion date: June 1, 2022
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Other:
• response to neoadjuvant chemotherapy
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).

Locations

Country	Name	City	State
China	Department of Gastric Surgery	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC for ICSS	The predictive performance of imaging change scoring system before and after neoadjuvant chemotherapy (ICSS)	2022-01-01 to 2022-07-31
Primary	AUC for BNCISS	The predictive performance of before neoadjuvant chemotherapy imaging scoring system (BNCISS)	2022-01-01 to 2022-07-31
Secondary	overall survival	3 year overall survival	2010-01-01 to 2022-07-31
Secondary	disease free survival	3 year disease free survival	2010-01-01 to 2022-07-31