Definitive Radiotherapy for Cervical and Upper Thoracic Esophageal Cancer (ChC&UES): A Multi-center Real World Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHebei Medical University Fourth Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

2,600 Participants
are grouped into 2 trial groups
Group A: High dose radiotherapy (≥60Gy)
Group B: Low dose radiotherapy (50-<60Gy)

Trial outcomes

Primary outcomes

1

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.

Time frame
2000.1.1-2024.6.20
2

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.

Time frame
2000.1.1-2024.6.20

Secondary outcomes

1

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.

Time frame
2000.1.1-2024.6.20

Other outcomes

1

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

Time frame
2000.1.1-2024.6.20

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