Real-world Study on Comprehensive Treatment of Esophageal Cancer Based on Precision Radiotherapy

Radiotherapy is one of the main treatments for locally advanced esophageal carcinoma (EC). The accuracy of the existing imaging methods in diagnosing and predicting therapeutic efficacy is disappointing, which increases the difficulty in clinical decision-making. In this study, based on a continuous cohort of EC treated with radiotherapy, the clinical and pathological factors of the patients are used to classify them into the appropriate therapeutic group. By multiple liquid biopsy technologies, combining with radiomics, we intend to construct prediction models of prognosis, therapeutic effect and toxicity. The aim of this RWS is to provide appropriate individualized regimen, further optimize the treatment mode based on precision radiotherapy and improve the outcome and quality of life of EC patients.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Radiation: 3DCRT

Detailed Description

Radiotherapy is one of the main treatments for locally advanced esophageal squamous cell carcinoma (ESCC). The guidelines recommend neoadjuvant concurrent chemoradiotherapy plus surgery for resectable or potentially resectable patients; for unresectable patients, definitive chemoradiotherapy is the standard treatment. However, due to the complexity of the biological behavior of esophageal cancer (EC) and individual differences, fully complying with guideline recommendations in clinical practice is difficult and idealized. The results of prospective clinical trials are difficult to meet the demand of clinical diagnosis and treatment, thus, carrying out high-quality real-world study (RWS) is necessary.

Three-dimensional conformal radiotherapy (3DCRT) for unresectable EC yields 5-year OS rates of 34%-45.6%, which is an improvement over the rates reported in the RTOG 85-01 and 94-05 studies. Even so, there is still room for improvement of local control rate and overall survival. The accuracy of the existing imaging methods [computed tomography (CT), magnetic resonance imaging (MRI), endoscopic ultrasonography (EUS), endoscopic ultrasonography (EUS), as well as positron-emission tomography (PET)-CT, etc.] in diagnosing and predicting therapeutic efficacy is disappointing, which increases the difficulty in clinical decision-making. It is worthy to investigate an appropriate individualized radiation regimen based on different treatment sensitivity.

In this study, based on a continuous cohort of EC treated with radiotherapy, the clinical and pathological factors of the patients are used to classify them into the appropriate therapeutic group. Collect the blood and saliva samples before, during and after radiotherapy; the remaining diagnostic biopsy tissue samples. By using multiple liquid biopsy technologies [microbial flora, circulating tumor DNA (ctDNA), genome, RNA, and immunophenotype, ect.], combining with radiomics, construct prediction models of prognosis, therapeutic effect and toxicity. The aim of this RWS is to provide appropriate individualized regimen, further optimize the treatment mode based on precision radiotherapy and improve the outcome and quality of life of EC patients.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
      • Contact: Wenyang Liu, MD; Phone Number: +86-13810753633; Email: liuwenyang26@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with esophageal cancer who are acceptable and tolerable to radiotherapy

Description

Inclusion Criteria:

• Pathology proved esophageal cancer
• ECOG PS ≤3
• Signed Informed consent

Exclusion Criteria:

• Pregnant and lactating women
• Others that researchers consider inappropriate

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-, 2-, 3-year overall survival	Overall survival	From treatment initiation to death from any cause or censor, assessed up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-, 2-, 3-year progression-free survival	Progression-free survival	From treatment initiation to first documented progression or death or censor, assessed up to 36 months
Rate of acute toxicity (any and above grade 3)	Toxicities according to CTCAE criteria	From enrollment to 3 months after treatment
Rate of acute/late toxicity (any and above grade 3)	Toxicities of chemoradiation therapy	After 3 months of enrollment
1-month short-term efficacy	Short-term efficacy	Assessed 1-month after radiotherapy (short-term) according to RECIST 1.1
Quality of Life change, QoL	measurement basing on EORTC (Quality of life of patients with oesophageal cancer) QLQ-C30 tables	1/3/6/12/24 months after radiotherapy
Quality of life of patients with oesophageal cancer	measurement basing on EORTC (Quality of life of patients with oesophageal cancer) QLQ-OES18 tables	1/3/6/12/24 months after radiotherapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers to predict radiotherapy efficacy	potential biomarkers in tumor samples and blood samples	baseline/through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: Zefen Xiao

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ANTICIPATED): January 1, 2026
• Study Completion (ANTICIPATED): January 1, 2026

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (ACTUAL): September 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Liquid biopsy; Prediction models; Real-world study; Individualized regimen
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: 22/036-3237

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No