Comparing chemoradiation and surgery for advanced esophageal cancer
A Randomized, Open-label, Multicenter Trial of the Chemoradiation Versus Standard Esophagectomy for Locally Advanced Resectable Esophageal Squamous Cell Cancer in Chinese Patients
This study is testing whether a combination of chemotherapy and radiation works better than surgery for Chinese patients with advanced esophageal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Henan University of Science and Technology Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Anyang, Henan and 1 other locations) |
| Trial ID | NCT02972372 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the outcomes of two treatment approaches for Chinese patients with locally advanced resectable esophageal squamous cell cancer. Patients will be randomly assigned to receive either definitive chemoradiation (CRT) or standard esophagectomy. The CRT group will undergo intensity-modulated radiation therapy combined with chemotherapy, while the surgery group will receive the standard surgical procedure. The study will follow patients for five years to assess disease-free survival and overall survival rates, as well as treatment-related adverse events and quality of life.
Who should consider this trial
Good fit: Ideal candidates are Chinese patients diagnosed with locally advanced resectable esophageal squamous cell cancer.
Not a fit: Patients with distant metastasis or serious premorbid conditions that compromise surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment approach for advanced esophageal cancer, potentially improving patient outcomes.
How similar studies have performed: While there is limited data on this specific comparison in Chinese patients, similar studies in other populations have shown promising results for both treatment approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Chinese * esophageal squamous cell cancer * mid or lower esophageal cancer * tumor is resectable disease * clinical stage: cT1bN+Mo, or cT2-4aN0-2M0 Exclusion Criteria: * who had distant metastasis to solid visceral organs or local invasion into trachea, descending aorta, or recurrent laryngeal nerve. * who had a serious premorbid condition or a poor physical status that compromised a thoracotomy.
Where this trial is running
Anyang, Henan and 1 other locations
- Anyang Tumor Hospital — Anyang, Henan, China (Recruiting)
- The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology — Luoyang, Henan, China (Recruiting)
Study contacts
- Principal investigator: Ruinuo Jia, MD — The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
- Study coordinator: Shegan Gao, MD, PhD
- Email: gsg112258@163.com
- Phone: +86 18638859977
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.