The aim of this study is to compare outcomes in Chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (CRT) by the randomized, open-label, multicenter trial.
Chinese
esophageal squamous cell cancer
mid or lower esophageal cancer
tumor is resectable disease
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.
Parallel
CRT
Procedure/SurgeryDrug: Capecitabine(Aibin) capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total Other Names: Aibin Drug: Oxaliplatin(Aiheng) Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V. Other Names: Aiheng cisplatin: 75mg/m2 d1，29 or d1, 29, 57, 85. 5-Fu：750mg/m2 CIV24h d1-4，d29-32 or d1-4，d29-32, d57-60, d85-88. Radiation: Radiotherapy concurrent radiotherapy：IMRT radiotherapy 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity
surgery
Procedure/SurgeryThe patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy
2-year disease-free survival rate
The percent of 2 year disease-free survival after random allocation, percent
Treatment-related adverse events
The percent of treatment-related adverse events after 2 year random allocation, percent
QoF (quality of life)
The quality of life evaluation after 2 year of random allocation by questionnaire, 1-10 score, 1 means poor and 10 means best
2 year overall survival
The percent of 2 year overall survival after random allocation, percent
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The First Affiliated Hospital of Henan University of Science and Technology
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborator
Anyang Tumor Hospital
Collaborator
150th Hospital of PLA
Collaborator
