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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05543057
Enrollment
150
Registered
2022-09-16
Start date
2020-01-01
Completion date
2026-01-01
Last updated
2022-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

Real-world study, Individualized regimen, Liquid biopsy, Prediction models

Brief summary

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.

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.

Interventions

RADIATION3DCRT

Three-dimensional conformal radiotherapy (3DCRT)

Sponsors

Zefen Xiao
Lead SponsorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years

Inclusion criteria

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

Exclusion criteria

* Pregnant and lactating women * Others that researchers consider inappropriate

Design outcomes

Primary

MeasureTime frameDescription
1-, 2-, 3-year overall survivalFrom treatment initiation to death from any cause or censor, assessed up to 36 monthsOverall survival

Secondary

MeasureTime frameDescription
Quality of Life change, QoL1/3/6/12/24 months after radiotherapymeasurement basing on EORTC (Quality of life of patients with oesophageal cancer) QLQ-C30 tables
1-, 2-, 3-year progression-free survivalFrom treatment initiation to first documented progression or death or censor, assessed up to 36 monthsProgression-free survival
1-month short-term efficacyAssessed 1-month after radiotherapy (short-term) according to RECIST 1.1Short-term efficacy
Rate of acute/late toxicity (any and above grade 3)After 3 months of enrollmentToxicities of chemoradiation therapy
Quality of life of patients with oesophageal cancer1/3/6/12/24 months after radiotherapymeasurement basing on EORTC (Quality of life of patients with oesophageal cancer) QLQ-OES18 tables
Rate of acute toxicity (any and above grade 3)From enrollment to 3 months after treatmentToxicities according to CTCAE criteria

Other

MeasureTime frameDescription
Biomarkers to predict radiotherapy efficacybaseline/through study completion, an average of 2 yearpotential biomarkers in tumor samples and blood samples

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026