Improve the Treatment of Thoracic Esophageal Cancer

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Thoracic Esophageal Squamous Cell Carcinoma

Treatments: Procedure: Total two field Lymphadenectomy; Procedure: three field Lymphadenectomy; Drug: adjuvant chemotherapy; Procedure: standard two field Lymphadenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01137123

2007044

Details and patient eligibility

About

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.

Full 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.

Enrollment: 301 patients

Sex: All

Ages: Under 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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301 participants in 6 patient groups

standard two field +follow-up

Active Comparator group

Treatment:

Procedure: standard two field Lymphadenectomy

standard two field +adjuvant chemotherapy

Experimental group

Treatment:

Drug: adjuvant chemotherapy

Procedure: standard two field Lymphadenectomy

total two field+follow-up

Experimental group

Treatment:

Procedure: Total two field Lymphadenectomy

total two field+adjuvant chemotherapy

Experimental group

Treatment:

Drug: adjuvant chemotherapy

Procedure: Total two field Lymphadenectomy

three field+follow-up

Experimental group

Treatment:

Procedure: three field Lymphadenectomy

three field+adjuvant chemotherapy

Experimental group

Treatment:

Drug: adjuvant chemotherapy

Procedure: three field Lymphadenectomy