NCT01137123

Improve the Treatment of Thoracic Esophageal Cancer

A Prospective Clinical Trial of Improving the Treatment of Thoracic Esophageal Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

According to different location of the primary lesion，the subject can be allocated to two sub-groups: The patient with upper or middle thoracic esophageal cancer may be assigned to two field(T)-total mediastinal lymphadenectomy group,which is control group in this study or three field lymphadenectomy-Abdominal + mediastinal + cervical lymphadenectomy group,which is study group in this study randomly. After the operation,the patient whose primary lesion is completely(R0) resected will be assigned to adjuvant chemotherapy group or interview group randomly.

Conditions

• Thoracic Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	adjuvant chemotherapy	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.
PROCEDURE	standard two field Lymphadenectomy	Standard two field lymphadenectomy is standard mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.
PROCEDURE	Total two field Lymphadenectomy	Total two field Lymphadenectomy is total mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.
PROCEDURE	three field Lymphadenectomy	Three field Lymphadenectomy includes abdominal,mediastinal and cervical lymphadenectomy.

Timeline

• Start date: 2010-04-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2010-06-04
• Last updated: 2022-03-31

Locations

1 site across 1 country: China