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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie paclitaxel and cisplatin synergy in lymph node-positive thoracic esophageal squamous cell carcinoma?
How does adjuvant paclitaxel/cisplatin regimen compare to standard postoperative therapies for advanced esophageal cancer in terms of efficacy and survival outcomes?
Which biomarkers correlate with response to paclitaxel and cisplatin in thoracic esophageal squamous cell carcinoma patients with lymph node metastases?
What are the most common adverse events associated with paclitaxel and cisplatin adjuvant chemotherapy in esophageal cancer and how are they managed?
Are there alternative platinum-based combination therapies being investigated for lymph node-positive thoracic esophageal squamous cell carcinoma compared to NCT02133612?
Trial Locations
- Locations (1)
Xiao Lv
🇨🇳Beijing, Beijing, China
Xiao Lv🇨🇳Beijing, Beijing, China