Improve the Treatment of Thoracic Esophageal Cancer

Phase 3

Completed

• Conditions: Thoracic Esophageal Squamous Cell Carcinoma
• Interventions: Procedure: standard two field Lymphadenectomy; Drug: adjuvant chemotherapy; Procedure: three field Lymphadenectomy; Procedure: Total two field Lymphadenectomy

• Registration Number: NCT01137123
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-06-03
• Study First Submitted QC: 2010-06-03
• Study First Posted: 2010-06-04
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2021-09
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
standard two field +follow-up	standard two field Lymphadenectomy	-
total two field+adjuvant chemotherapy	adjuvant chemotherapy	-
three field+follow-up	three field Lymphadenectomy	-
total two field+follow-up	Total two field Lymphadenectomy	-
standard two field +adjuvant chemotherapy	adjuvant chemotherapy	-
standard two field +adjuvant chemotherapy	standard two field Lymphadenectomy	-
three field+adjuvant chemotherapy	adjuvant chemotherapy	-
three field+adjuvant chemotherapy	three field Lymphadenectomy	-
total two field+adjuvant chemotherapy	Total two field Lymphadenectomy	-

Primary Outcome Measures

Name	Time	Method
survival rate	5 years	1. Disease-free survival; 2. overall survival

Trial Locations

Locations (1)

Sun Yat-sen Uniersity Cancer Center; 🇨🇳 GuangZhou, Guangdong, China