Clinical trial NCT01137123: Improve the Treatment of Thoracic Esophageal Cancer
Official title: A Prospective Clinical Trial of Improving the Treatment of Thoracic Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thoracic Esophageal Squamous Cell Carcinoma
Keywords: esophageal squamous cell carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2010-06-04
Enrollment: 301
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: survival rate
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Sun Yat-sen Uniersity Cancer Center
state: Guangdong
Study officials:
affiliation: 651, Dongfeng Road East, Guangzhou, P. R. China
name: Peng Lin, Professor
role: PRINCIPAL_INVESTIGATOR
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