About this trial
Cervical and upper thoracic esophageal cancer (ESCA) presents treatment challenges due to limited clinical evidence. This multi-center study (ChC\&UES) explores radical radio(chemo)therapy efficacy and safety
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 and older.
Confirmation of esophageal cancer through histopathology or cytology.
Primary tumor location within the cervical or upper thoracic segment, extending from the upper esophageal sphincter to the azygos vein.
Absence of distant metastasis.
Disqualifiers
Receipt of radiation dose below 50Gy.
History of other malignancies (except for cured cancer in situ and malignancies cured for over 5 years) or laryngeal invasion.
Diagnosis of double primary esophageal cancer.
Prior chest radiation therapy within the past 5 years.
Trial population
This study is a real-world study. All esophageal cancer patients over 18 years old who received radical radiotherapy in cervical and upper thoracic segment eligible for inclusion were retrospectively collected. This study is a reflection of real-world, no restriction on treatment was made.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Overall survival time (OS)
Compared the differences in overall survival (OS) between low dose radiation and high dose radiation group after definitive radiotherapy. OS is defined as time from start of enrollment to death from any cause.
progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the start of enrollment until tumor progression or death from any cause.
Secondary outcomes
Objective response rate (ORR)
The Objective Response Rate (ORR) is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Measures the effectiveness of a cancer treatment by showing the percentage of patients whose tumors shrink significantly within a specified time. ORR includes: Complete Response (CR): All target tumors disappear, and no new tumors appear.Partial Response (PR): The size of target tumors decreases by at least 30%, and no new tumors appear. The proportion of patients who achieve CR+PR was ORR.
Other outcomes
Side effect
The investigators employed the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, to assess treatment-related adverse effects during and after the course of treatmen
Sponsors and contacts
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Hebei Medical University Fourth Hospital
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborator
Fujian Cancer Hospital
Collaborator
Fudan University
Collaborator
Shandong Cancer Hospital and Institute
Collaborator