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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-Sen University Cancer Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • chemotherapy

    Drug

    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 groups

232 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Disease-free survival

Patients were images with computed tomography (CT) scan

Time frame
At most 5 years after enrollment

Secondary outcomes

1

overall survival

Patients were images with computed tomography (CT) scan

Time frame
At most 5 years after enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-Sen University Cancer Center

Lead sponsor

Sun Yat-sen University

Sponsor institution