Esophageal Cancer
Conditions
Keywords
esophageal cancer, adjuvant chemotherapy, esophageal surgery, paclitaxel, cisplatin
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.
Interventions
The adjuvant chemotherapy regimen consisted of paclitaxel 150mg/m2 intravenously (IV) over 3 hours on day 1, followed by cisplatin 50mg/m2 IV on day 2 every 14 days for 4 to 6 cycles.
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 year overall survival | 5 year |
Secondary
| Measure | Time frame |
|---|---|
| 3 year disease-free survival | 5 year |
Other
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events | 5 year |
Countries
China
Outcome results
None listed