Thoracic Esophageal Squamous Cell Carcinoma
Conditions
Keywords
adjuvant chemotherapy
Brief summary
Patients with thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomized into the adjuvant chemotherapy group or the postoperative observation group
Detailed description
Patients with T≥3 or N≥1 thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomly enrolled into the experimental group for adjuvant chemotherapy or the controlled group for postoperative observation. The experimental group received 4-course chemotherapy of docetaxel combined with nedaplatin, and to observe the 3-year progression free survival (DFS) and 5-year overall survival (OS) in two groups.
Interventions
DRUGchemotherapy
patients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma began to receive chemotherapy of docetaxel combined with nedaplatin within 8 weeks after total two-field lymph node dissection. Docetaxel 75mg/m2 day 1, nedaplatin 75mg/m2 day 1, every 21 days for 4 cycles
Sponsors
Sun Yat-Sen University Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with esophageal squamous cell carcinoma who received radical surgical resection and total two-field lymph node dissection did not receive neoadjuvant therapy before surgery, and didn't suffer serious complications after surgery. 2. T≥3 or N≥1, and more than 15 lymph nodes were dissected. 3. Age ≥18 years and ≤75 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 5. Adequate hematological function: absolute neutrophil count (ANC) ≥ 1.5×109/L, and blood platelet count (PLT) ≥ 1.5×109/L, and hemoglobin ≥ 9g/dL. 6. Adequate hepatic function: total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase ≤2.5 × ULN. 7. Adequate renal function: serum creatinine ≤1.5 × ULN and creatinine clearance ≥50 ml/min. 8. Subjects could understand and comply with study and follow-up procedures, and voluntarily signed written informed consent
Exclusion criteria
1. Suffering from previous primary malignancy or co-existing serious illness of other organs, which will affect the judgment of the end point of this study. 2. Serious postoperative complications that will affect progress of chemotherapy. 3. Patients with chemotherapy contraindications. 4. Women who are pregnant or breast-feeding or who are planning for pregnancy. 5. Unable to complete the follow-up as planned. 6. Without informed consent due to psychological, family, social and other factors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | At most 5 years after enrollment | Patients were images with computed tomography (CT) scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | At most 5 years after enrollment | Patients were images with computed tomography (CT) scan |
Countries
China
Contacts
CONTACTPeng Lin, professor
CONTACTXing Ru Ping
Outcome results
None listed