Study on Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma

Sun Yat-sen University

Status: Enrolling

Conditions: Thoracic Esophageal Squamous Cell Carcinoma

Treatments: Drug: chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04174079

B2019-061-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 232 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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232 participants in 2 patient groups

Experimental group

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

Treatment:

Drug: chemotherapy

control group

No Intervention group

Description:

patients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma were reviewed regularly after surgery.