Thoracic Esophageal Squamous Cell Carcinoma
Conditions
Keywords
esophageal squamous cell carcinoma
Brief 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.
Interventions
DRUGadjuvant 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.
PROCEDUREstandard 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.
PROCEDURETotal 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.
PROCEDUREthree field Lymphadenectomy
Three field Lymphadenectomy includes abdominal,mediastinal and cervical lymphadenectomy.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| survival rate | 5 years | 1. Disease-free survival 2. overall survival |
Countries
China
Outcome results
None listed