Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma
- Registration Number
- NCT02133612
- Lead Sponsor
- Chinese Academy of Medical Sciences
- Brief Summary
Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.
* Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases.
* No standard postoperative adjuvant chemotherapy has ever been established.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
- ability to give informed consent
- histological proof of thoracic esophageal squamous cell carcinoma with negative proximal and distal margins
- node-positive and pathologic stage M0 .
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Patients were enrolled 4 to 10 weeks after surgery.
- Adequate organ function was required in 2 weeks of registration and was defined as: serum creatinine within normal institutional limit, and creatinine clearance (CrCl) ≥60ml/minute. Aspartate aminotransferase and bilirubin<2 times of upper normal institutional limits.
Exclusion Criteria
- prior chemotherapy or concurrent radiation therapy before esophagectomy
- R1 or R2 resection
- clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description single arm paclitaxel and cisplatin paclitaxel; cisplatin -
- Primary Outcome Measures
Name Time Method 3 year overall survival 5 year
- Secondary Outcome Measures
Name Time Method 3 year disease-free survival 5 year
Trial Locations
- Locations (1)
Xiao Lv
🇨🇳Beijing, Beijing, China