Improve the Treatment of Thoracic Esophageal Cancer

Study Overview
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Brief Summary
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The purpose of this study is 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. 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
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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.

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

Conditions
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Thoracic Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: adjuvant chemotherapy
* Procedure: standard two field Lymphadenectomy
* Procedure: Total two field Lymphadenectomy
* Procedure: three field Lymphadenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≤70 years old; Karnofsky Performance Status（KPS）≥80; Pathological diagnosis is squamous cell carcinoma of thoracic esophageal which is treated initially; Clinical stage is c T 1   3 N 0   1 according to the results of endoscopic ultrasonography，chest and abdomen CT and neck ultrasonic. The preoperative evaluation of organ function is tolerant of surgery and chemotherapy; The subject can understand and sign the informed consent form (ICF); The following laboratory tests, made in 4 weeks before first medication, confirmed that bone marrow, liver and kidney function in line with the requirements to participate in research; Hemoglobin（HGB）≥9.0g/L; absolute neutrophils count（ANC）≥1.5×109/L; platelet count（PLT）≥100×109/L; total bilirubin（TBIL）≤1.5N;aspartate aminotransferase (AST)≤2.5N;alanine aminotransferase(ALT)≤2.5N;prothrombin time(PT)≤1.5N, and activated partial thromboplastin time(APTT) is in normal range;endogenous creatinine clearance rate(CRE)≤1.5N. Exclusion Criteria: Cervical esophageal cancer and Non-squamous cell carcinoma of thoracic esophageal cancer; Advanced Esophageal Cancer; Prior malignancy in 5 years recently; History of previous chest radiotherapy; History of cardio-cerebral vascular accident in 6 months lately; The subject can not understand and sign the informed consent form(ICF).

Ages Eligible for Study
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Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard two field +follow-up<br> | Procedure: standard two field Lymphadenectomy<br>* Standard two field lymphadenectomy is standard mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.<br>* Other names: two field(S);|
| Experimental: standard two field +adjuvant chemotherapy<br> | Drug: adjuvant chemotherapy<br>* 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.<br>Procedure: standard two field Lymphadenectomy<br>* Standard two field lymphadenectomy is standard mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.<br>* Other names: two field(S);|
| Experimental: total two field+follow-up<br> | Procedure: Total two field Lymphadenectomy<br>* Total two field Lymphadenectomy is total mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.<br>* Other names: two field(T);|
| Experimental: total two field+adjuvant chemotherapy<br> | Drug: adjuvant chemotherapy<br>* 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.<br>Procedure: Total two field Lymphadenectomy<br>* Total two field Lymphadenectomy is total mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.<br>* Other names: two field(T);|
| Experimental: three field+follow-up<br> | Procedure: three field Lymphadenectomy<br>* Three field Lymphadenectomy includes abdominal,mediastinal and cervical lymphadenectomy.<br>* Other names: three field;|
| Experimental: three field+adjuvant chemotherapy<br> | Drug: adjuvant chemotherapy<br>* 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.<br>Procedure: three field Lymphadenectomy<br>* Three field Lymphadenectomy includes abdominal,mediastinal and cervical lymphadenectomy.<br>* Other names: three field;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate | Disease-free survival overall survival | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal squamous cell carcinoma