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Trial Title:
Real-world Study on Comprehensive Treatment of Esophageal Cancer Based on Precision Radiotherapy
NCT ID:
NCT05543057
Condition:
Esophageal Cancer
Conditions: Official terms:
Esophageal Neoplasms
Conditions: Keywords:
Real-world study
Individualized regimen
Liquid biopsy
Prediction models
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Radiation
Intervention name:
3DCRT
Description:
Three-dimensional conformal radiotherapy (3DCRT)
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.
Criteria for eligibility:
Study pop:
Patients with esophageal cancer who are acceptable and tolerable to radiotherapy
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Pathology proved esophageal cancer
- ECOG PS ≤3
- Signed Informed consent
Exclusion Criteria:
- Pregnant and lactating women
- Others that researchers consider inappropriate
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Locations:
Facility:
Name:
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)
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Zefen Xiao, MD
Phone:
+86-13621018159
Email:
xiaozefen@sina.com
Contact backup:
Last name:
Wenyang Liu, MD
Phone:
+86-13810753633
Email:
liuwenyang26@163.com
Start date:
January 1, 2020
Completion date:
January 1, 2026
Lead sponsor:
Agency:
Zefen Xiao
Agency class:
Other
Source:
ChineseAMS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05543057
