Clinical trial NCT05543057: Real-world Study on Comprehensive Treatment of Esophageal Cancer Based on Precision Radiotherapy
Official title: Real-world Study on Comprehensive Treatment of Esophageal Cancer Based on Precision Radiotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Cancer
Keywords: Real-world study
Individualized regimen
Liquid biopsy
Prediction models
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2022-09-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with esophageal cancer who are acceptable and tolerable to radiotherapy

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnant and lactating women
* Others that researchers consider inappropriate

Primary outcomes:
measure: 1-, 2-, 3-year overall survival
timeFrame: From treatment initiation to death from any cause or censor, assessed up to 36 months
Secondary outcomes:
measure: 1-, 2-, 3-year progression-free survival
timeFrame: From treatment initiation to first documented progression or death or censor, assessed up to 36 months
measure: Rate of acute toxicity (any and above grade 3)
timeFrame: From enrollment to 3 months after treatment
measure: Rate of acute/late toxicity (any and above grade 3)
timeFrame: After 3 months of enrollment
measure: 1-month short-term efficacy
timeFrame: Assessed 1-month after radiotherapy (short-term) according to RECIST 1.1
measure: Quality of Life change, QoL
timeFrame: 1/3/6/12/24 months after radiotherapy
measure: Quality of life of patients with oesophageal cancer
timeFrame: 1/3/6/12/24 months after radiotherapy
Other outcomes:
measure: Biomarkers to predict radiotherapy efficacy
timeFrame: baseline/through study completion, an average of 2 year
Locations:
city: Beijing
country: China
facility: 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)
state: Beijing
Study officials:
References: