Chemoradiation Versus Esophagectomy for Locally 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
The First Affiliated Hospital of Henan University of Science and Technology
196 participants
Nov 1, 2016
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- Chinese
- esophageal squamous cell cancer
- mid or lower esophageal cancer
- tumor is resectable disease
- clinical stage: cT1bN+Mo, or cT2-4aN0-2M0
Exclusion Criteria2
- 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.
Interventions
Drug: 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
The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT02972372