Response Prediction to Neoadjuvant Chemoradiation in Esophageal Cancer Using Artificial Intelligence & Machine Learning

Esophageal Neoplasm Clinical Trial

— QARC  

Official title:

Pathological Response Prediction to Neo-adjuvant Chemoradiotherapy in Esophageal Carcinoma and Comparison of Engineered Features Versus Deep Learning Models

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04489368
• Other study ID #: RGCIRC/IRB/80/2020
• Status: Active, not recruiting
• Start date: January 16, 2020
• Est. completion date: July 2023

Study information

• Verified date: December 2022
• Source: Rajiv Gandhi Cancer Institute & Research Center, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In esophageal carcinoma, neoadjuvant concurrent chemo-radiotherapy (NA-CCRT) followed by surgery is the current standard of care and ample evidence has accumulated supporting the view that complete pathological response (pCR) is a positive prognostic marker for improved outcomes. Predicting the probability of achieving pCR prior to neoadjuvant treatment could permit modification of treatment protocols for those patients unlikely to achieve pCR.

Radiomics is a new entrant in the field of imaging where specific features are derived from the intensity and distribution pattern of pixels based on a region-of-interest (ROI). The features thus extracted can then be used for prediction modelling similar to other -omics datasets. Preliminary investigations examining its utility have been performed and its applications have thus far focused on screening and survival prediction after treatment. Due to the multi-dimensional nature of data extracted using radiomics, Artificial Intelligence (AI) methods are ideally suited for analysing and modelling radiomic features.

Machine Learning (ML) and Deep Learning (DL)[utilising Convolutional Neural Networks (CNN)] are both part of the AI framework. In contrast to ML, DL is a new entrant and has been utilised by some medical researchers for modelling using prediction-type algorithms. Besides significantly reducing the workflow associated with Radiomics-based research, feature engineering and modelling using DL are immune to the effects of incorrect ROI delineation. However, the main limitation of DL is the 'blackbox' effect, in which the underlying basis of a CNN is not known. This has been mitigated in part by the visualisation of activation maps directly on the image dataset to prove biological plausibility of predictions. The comparative performance of both types of modelling is also not known.

Our objective is to investigate pCR probability in our study population using radiomics-based ML and AI-based modelling. We will also investigate the comparative performance of both modelling techniques. For DL based prediction modelling, we will attempt to provide biological plausibility on the basis of activation maps.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ECOG Performance Status: 0-2

• Patients with histopathological or cytopathological confirmed malignancy of the esophagus

• Histology: Squamous Cell Carcinoma and Adenocarcinoma

• Patients should have received NeoAdjuvant Concurrent Chemoradiation (NACCRT) followed by Surgery

• All therapeutic interventions (Radiotherapy, Chemotherapy & Surgery) delivered within participating institutions

• At least one pre-NACCRT DICOM imaging dataset (HRCT/ 18-FDG PET-CT/ Radiotherapy planning CT) for each patient

Exclusion Criteria:

• Patients with any metallic implants in the region of interest

• Patient with locally advanced disease or metastatic disease (T4 disease, Fistula, metastases)

• Patients with prior history of radiotherapy in the same region

• Patients developing a second malignancy in the esophagus

Related Conditions & MeSH terms

• Esophageal Neoplasm
• Esophageal Neoplasms

Intervention

Radiation:
• Neo-Adjuvant Radiotherapy
Neo-Adjuvant Radiotherapy via any technique, delivered concurrently with Neo-Adjuvant Chemotherapy.

Drug:
• Neo-Adjuvant Chemotherapy
Neo-Adjuvant Chemotherapy, delivered concurrently with Neo-Adjuvant Radiotherapy.

Procedure:
• Esophagectomy
Esophagectomy, performed 4-6 weeks after completion of Neo-Adjuvant Concurrent ChemoRadiation

Locations

Country	Name	City	State
Australia	Illawarra Cancer Care Centre	Wollongong
India	Rajiv Gandhi Cancer Institute & Research Center	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Dr Kundan Singh Chufal

Countries where clinical trial is conducted

Australia,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Develop models to predict pCR based on pre-neoadjuvant imaging modalities		August 2021
Primary	Perform a clinical audit of patient outcomes (OS, RFS, pCR rate) after new-adjuvant chemoradiation and esophagectomy		January 2020