Exploring Radiotherapy for Cervical and Upper Thoracic Esophageal Cancer
Definitive Radiotherapy for Cervical and Upper Thoracic Esophageal Cancer (ChC&UES): A Multi-center Real World Study
This study is testing how effective and safe different doses of radiation therapy are for people with cervical and upper thoracic esophageal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hebei Medical University Fourth Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Shijiazhuang, Hebei) |
| Trial ID | NCT06481449 on ClinicalTrials.gov |
What this trial studies
This multi-center observational study investigates the efficacy and safety of radical radiotherapy for patients with cervical and upper thoracic esophageal cancer (ESCA). It categorizes patients into low and high dose radiation groups and collects comprehensive clinical data, including treatment methods and outcomes. The study aims to analyze overall survival rates using statistical methods such as Kaplan-Meier and Cox regression modeling. By focusing on real-world treatment scenarios, it seeks to provide valuable insights into optimal radiation dosing for this rare cancer.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed cervical or upper thoracic esophageal cancer who are unable or unwilling to undergo surgical treatment.
Not a fit: Patients with distant metastasis or those who have received prior chest radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and survival rates for patients with cervical and upper thoracic esophageal cancer.
How similar studies have performed: While there is limited clinical evidence for this specific approach, similar studies have explored radiotherapy efficacy in esophageal cancer, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 and older. 2. Confirmation of esophageal cancer through histopathology or cytology. 3. Primary tumor location within the cervical or upper thoracic segment, extending from the upper esophageal sphincter to the azygos vein. 4. Absence of distant metastasis. 5. Patients unable or unwilling to undergo surgical treatment for various reasons. 6. Receipt of radical radiotherapy as the first-line treatment, with or without chemotherapy, immunotherapy, or targeted therapy. 7. Undergoing conventional radiation therapy (1.8-2.0Gy per session, once per day). 8. Receiving 3DCRT or IMRT radiotherapy. 9. Availability of complete radiotherapy prescription dose information and follow-up records. Exclusion Criteria: 1. Receipt of radiation dose below 50Gy. 2. History of other malignancies (except for cured cancer in situ and malignancies cured for over 5 years) or laryngeal invasion. 3. Diagnosis of double primary esophageal cancer. 4. Prior chest radiation therapy within the past 5 years. 5. Recurrent or metastatic esophageal cancer. 6. Receipt of 2D radiotherapy, large fractionation, or hyper-fractionation radiotherapy. 7. Patients with incomplete radiotherapy dose and follow-up data.
Where this trial is running
Shijiazhuang, Hebei
- Because this study is a response to real-world patient treatment and outcomes — Shijiazhuang, Hebei, China (Recruiting)
Study contacts
- Principal investigator: Wenbin Shen — Hebei Medical University Fourth Hospital
- Study coordinator: Wenbin Shen
- Email: wbshen2024@hebmu.edu.cn
- Phone: +86 15831183879
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.