Study on Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: chemotherapy.
- Who it may be relevant to
- Registry conditions: Thoracic Esophageal Squamous Cell Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Randomized Controlled Clinical Trial of Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma
Overview
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
- Drug chemotherapy
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
Primary outcome measures
- Disease-free survival [Time frame: At most 5 years after enrollment]
Secondary outcome measures (1)
- overall survival [Time frame: At most 5 years after enrollment]
Eligibility criteria
Inclusion criteria
- 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.
- T≥3 or N≥1, and more than 15 lymph nodes were dissected.
- Age ≥18 years and ≤75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate hematological function:
absolute neutrophil count (ANC) ≥ 1.5×109/L, and blood platelet count (PLT) ≥ 1.5×109/L, and hemoglobin ≥ 9g/dL.
- Adequate hepatic function: total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase ≤2.5 × ULN.
- Adequate renal function:
serum creatinine ≤1.5 × ULN and creatinine clearance ≥50 ml/min.
- Subjects could understand and comply with study and follow-up procedures, and voluntarily signed written informed consent
Exclusion criteria
- 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.
- Serious postoperative complications that will affect progress of chemotherapy.
- Patients with chemotherapy contraindications.
- Women who are pregnant or breast-feeding or who are planning for pregnancy.
- Unable to complete the follow-up as planned.
- Without informed consent due to psychological, family, social and other factors.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen Uniersity Cancer Center — Guangzhou
Identifiers
NCT: NCT04174079 · B2019-061-01