Status:
COMPLETED
Improve the Treatment of Thoracic Esophageal Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Thoracic Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE3
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 th...
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT01137123
Start Date
April 1 2010
End Date
December 1 2020
Last Update
March 31 2022
Active Locations (1)
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1
Sun Yat-sen Uniersity Cancer Center
Guangzhou, Guangdong, China, 510060