At a glance
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A Prospective Clinical Trial of Improving the Treatment of Thoracic Esophageal Cancer
In Brief
A Phase 3 clinical trial evaluating adjuvant chemotherapy, standard two field Lymphadenectomy, and 2 other interventions for Thoracic Esophageal Squamous Cell Carcinoma. Completed, enrolled 301 participants across 1 site.
Detailed Summary
The purpose of this study is 1. To compare the effects of the two types of thoracic esophageal cancer lymphadenectomy on the staging and prognosis of resectable esophageal cancer, which defined by the International Association of esophageal disease(ISDE) - standard mediastinal lymphadenectomy,total mediastinal lymphadenectomy and three field lymphadenectomy,and to find out reasonable range of lymphadenectomy. 2. To compare the effects of Chemotherapy Group (Docetaxel + Nedaplatin) with Control Group on the prognosis of resectable thoracic esophageal cancer,and to explore the indications of adjuvant chemotherapy.
Study Details
Timeline
Interventions
Docetaxel 75mg/m2 +Nedaplatin 75mg/m2,IV drip on day 1 of each 21 day cycle. Number of cycles: till unacceptable toxicity develops and no more than 4 cycles.
Standard two field lymphadenectomy is standard mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.
Total two field Lymphadenectomy is total mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.
Three field Lymphadenectomy includes abdominal,mediastinal and cervical lymphadenectomy.