Improve the Treatment of Thoracic Esophageal Cancer
Conditions
Thoracic Esophageal Squamous Cell Carcinoma
Conditions: official terms
Carcinoma, Squamous Cell - Esophageal Neoplasms
Conditions: Keywords
esophageal squamous cell carcinoma
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: adjuvant chemotherapy Type: Drug
Name: standard two field Lymphadenectomy Type: Procedure
Name: Total two field Lymphadenectomy Type: Procedure
Name: three field Lymphadenectomy Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: N/A
Gender: Both
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).
Location
Sun Yat-sen Uniersity Cancer Center
GuangZhou, Guangdong, China
Status: Recruiting
Contact: Peng Lin, Professor - +86-20-87343314 - linpeng@sysucc.org.cn
Start Date
April 2010
Completion Date
December 2017
Sponsors
Sun Yat-sen University
Source
Sun Yat-sen University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page