A Randomized, Open-label, Multicenter Trial Comparing Chemoradiation With Standard Esophagectomy for Locally Advanced Resectable Esophageal Squamous Cell Cancer in Chinese Patients

What this Trial Is About

Researchers are evaluating treatments for locally advanced resectable esophageal squamous cell cancer in Chinese patients. This trial compares two approaches: surgery (esophagectomy) and definitive chemoradiation therapy (CRT). The study aims to better understand which treatment leads to improved outcomes, including disease-free survival and overall survival, with a follow-up period of five years. This is an open-label, randomized, multicenter trial involving 176 patients. Participants are randomly assigned to one of two groups. The CRT group receives intensity modulation radiation therapy (IMRT) delivering a total of 50 Gy in 25 fractions combined with chemotherapy involving drugs such as capecitabine, oxaliplatin, cisplatin, and 5-fluorouracil over several weeks. The surgery group undergoes standard esophagectomy performed openly with two-field lymphadenectomy. Both groups are followed for up to five years to monitor outcomes and side effects. During the study, patients will be regularly monitored for disease progression, treatment-related adverse events, and quality of life. Key outcome measures include 2-year and 5-year disease-free survival and overall survival. Researchers will also assess treatment safety and participants' quality of life over two years. The study is sponsored by The First Affiliated Hospital of Henan University of Science and Technology and includes adults aged 18 to 75 years.

Chemoradiation Versus Esophagectomy for Locally Advanced Esophageal Cancer