Actively Recruiting
Definitive Radiotherapy for Cervical and Upper Thoracic Esophageal Cancer (ChC&UES): A Multi-center Real World Study
Led by Hebei Medical University Fourth Hospital · Updated on 2024-07-01
2600
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
H
Hebei Medical University Fourth Hospital
Lead Sponsor
T
Tianjin Medical University Cancer Institute and Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Cervical and upper thoracic esophageal cancer (ESCA) are uncommon types of esophageal cancer that present challenges in treatment due to limited clinical evidence. This multi-center real-world study investigates the effectiveness and safety of radical radiotherapy, with a special focus on the radiation dose, to better understand outcomes for patients with these cancers. The research collects detailed patient data from six medical centers in China to compare different radiation dose groups and their impact on survival and side effects. The study divides patients into two groups based on the radiation dose received during radical radiotherapy for the primary tumor: a high dose group receiving 60 Gy or more, and a low dose group receiving between 50 and less than 60 Gy. All patients underwent conventional radiation therapy with sessions of 1.8 to 2.0 Gy once daily using 3D conformal radiotherapy (3DCRT) or intensity-modulated radiotherapy (IMRT). Some patients also received chemotherapy, immunotherapy, or targeted therapy alongside radiotherapy as part of their treatment. Participants are monitored with regular follow-up to collect data on overall survival time, progression-free survival, treatment response, toxicity, and side effects. The study uses statistical methods to analyze survival differences and factors affecting outcomes. Complete treatment and follow-up records are maintained to ensure comprehensive assessment. The study period spans from January 2000 to June 2024, allowing long-term evaluation of treatment effects.
CONDITIONS
Brief Title
Definitive Radiotherapy for Cervical and Upper Thoracic Esophageal Cancer (ChC&UES): A Multi-center Real World Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 and older
- Confirmed diagnosis of esophageal cancer by histopathology or cytology
- Primary tumor located in cervical or upper thoracic esophagus (from upper esophageal sphincter to azygos vein)
- No distant metastasis present
- Unable or unwilling to have surgery for various reasons
- Receiving radical radiotherapy as first-line treatment, with or without chemotherapy, immunotherapy, or targeted therapy
- Undergoing conventional radiation therapy with 1.8-2.0 Gy per session, once daily
- Receiving 3DCRT or IMRT radiotherapy
- Complete radiotherapy dose information and follow-up records available
You will not qualify if you...
- Radiation dose less than 50 Gy
- History of other cancers except cured cancer in situ or malignancies cured over 5 years ago
- Laryngeal invasion
- Diagnosis of double primary esophageal cancer
- Chest radiation therapy within past 5 years
- Recurrent or metastatic esophageal cancer
- Use of 2D radiotherapy, large fractionation, or hyper-fractionation radiotherapy
- Incomplete radiotherapy dose or follow-up data
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of radiotherapy treatment period (variable)
Participants who undergo routine radical radiotherapy for cervical and upper thoracic esophageal cancer are observed. Clinical information and treatment data including radiation dose, chemotherapy, immunotherapy, and targeted therapy usage are collected.
1 daily visit for radiotherapy sessions
Duration - Up to 24 years of follow-up
Participants are followed over time to assess overall survival, progression-free survival, treatment efficacy, and side effects.
Periodic follow-up visits during the study period
Trial Site Locations
Total: 1 location
1
Because this study is a response to real-world patient treatment and outcomes
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
Research Team
W
Wenbin Shen
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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