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

NCT05543057 | Unknown

• 1 other identifier: 22/036-3237
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 1-, 2-, 3-year overall survival

  Overall survival

  From treatment initiation to death from any cause or censor, assessed up to 36 months

Secondary Outcomes (6)

• 1-, 2-, 3-year 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)

  From enrollment to 3 months after treatment

• Rate of acute/late toxicity (any and above grade 3)

  After 3 months of enrollment

• 1-month short-term efficacy

  Assessed 1-month after radiotherapy (short-term) according to RECIST 1.1

• Quality of Life change, QoL

  1/3/6/12/24 months after radiotherapy

Other Outcomes (1)

• Biomarkers to predict radiotherapy efficacy

  baseline/through study completion, an average of 2 year

Interventions

3DCRT RADIATION

Three-dimensional conformal radiotherapy (3DCRT)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with esophageal cancer who are acceptable and tolerable to radiotherapy

You may qualify if:

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

You may not qualify if:

• Pregnant and lactating women
• Others that researchers consider inappropriate

Sponsors & Collaborators

• Zefen Xiao: lead

Study Sites (1)

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)

Beijing, Beijing Municipality, 100021, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The blood and saliva samples before, during and after radiotherapy; the remaining diagnostic biopsy tissue samples.

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 16, 2022
• Study Start: January 1, 2020
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 16, 2022

Record last verified: 2022-09

Locations

CN (1)