Clinical trial · Interventional
Study on Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma
A Prospective, Randomized Controlled Clinical Trial of Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma
NCT04174079CI-TRIAL-00118769recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thoracic Esophageal Squamous Cell Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- 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
- interventionNames
- Drug: chemotherapy
- type
- NO_INTERVENTION
- label
- control group
- description
- patients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma were reviewed regularly after surgery.
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- At most 5 years after enrollment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.