Improve the Treatment of Thoracic Esophageal Cancer

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

Inclusion Criteria:

1. Age≤70 years old;

2. Karnofsky Performance Status（KPS）≥80;

3. Pathological diagnosis is squamous cell carcinoma of thoracic esophageal which is treated initially;

4. Clinical stage is c T 1 ~ 3 N 0 ~ 1 according to the results of endoscopic ultrasonography，chest and abdomen CT and neck ultrasonic.

5. The preoperative evaluation of organ function is tolerant of surgery and chemotherapy;

6. The subject can understand and sign the informed consent form (ICF);

7. 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:

1. Cervical esophageal cancer and Non-squamous cell carcinoma of thoracic esophageal cancer;

2. Advanced Esophageal Cancer;

3. Prior malignancy in 5 years recently;

4. History of previous chest radiotherapy;

5. History of cardio-cerebral vascular accident in 6 months lately;

6. The subject can not understand and sign the informed consent form(ICF).