Clinical trial NCT04489368: Response Prediction to Neoadjuvant Chemoradiation in Esophageal Cancer Using Artificial Intelligence & Machine Learning
Official title: Pathological Response Prediction to Neo-adjuvant Chemoradiotherapy in Esophageal Carcinoma and Comparison of Engineered Features Versus Deep Learning Models
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Neoplasm
Keywords: Artificial Intelligence
Deep Learning
Neoadjuvant Chemoradiation
Pathologic Response
Radiomics
Radiotherapy
Lead sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient records in each participating research center from January 2011 to 1st May 2020

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Develop models to predict pCR based on pre-neoadjuvant imaging modalities
timeFrame: August 2021
measure: Perform a clinical audit of patient outcomes (OS, RFS, pCR rate) after new-adjuvant chemoradiation and esophagectomy
timeFrame: January 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Wollongong
country: Australia
facility: Illawarra Cancer Care Centre
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute & Research Center
state: Delhi
Study officials:
affiliation: Rajiv Gandhi Cancer Institute & Research Center
name: Kundan S Chufal, MD
role: PRINCIPAL_INVESTIGATOR
References: