NCT02461043
Unknown
Phase 3
Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma: A Randomized Phase 3 Trial
Overview
- Phase
- Phase 3
- Intervention
- paclitaxel; cisplatin
- Conditions
- Esophageal Cancer
- Sponsor
- Chinese Academy of Medical Sciences
- Enrollment
- 386
- Locations
- 1
- Primary Endpoint
- 3 year relapse free survival
- Last Updated
- 10 years ago
Overview
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.
Investigators
Jie He
MD.,PhD
Chinese Academy of Medical Sciences
Eligibility Criteria
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
Arms & Interventions
Arm A
chemotherapy and radiotherapy
Intervention: paclitaxel; cisplatin
Arm A
chemotherapy and radiotherapy
Intervention: radiation
Arm B
radiotherapy
Intervention: radiation
Outcomes
Primary Outcomes
3 year relapse free survival
Time Frame: 5 years
Secondary Outcomes
- 3 year overall survival(5 years)
Study Sites (1)
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