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

Launched by SUN YAT-SEN UNIVERSITY · Nov 21, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of adjuvant chemotherapy in patients who have undergone surgery to remove thoracic esophageal squamous cell carcinoma, a type of cancer in the esophagus. After surgery, participants are randomly placed into two groups: one group will receive chemotherapy to help prevent cancer from returning, while the other group will only be monitored without additional treatment. The goal is to find out if chemotherapy after surgery improves outcomes for these patients.

To be eligible for this study, patients should be between 18 and 75 years old and have undergone a complete surgical removal of their esophageal cancer, along with the removal of at least 15 lymph nodes. They should not have received any treatment before surgery and must be in good overall health, meaning they have no serious complications from the surgery and can understand and participate in the study. Participants can expect regular check-ups during the trial, and all their progress will be closely monitored. This study is currently recruiting participants, so those who meet the criteria and are interested in joining will have the opportunity to contribute to important research in cancer treatment.

Gender

ALL

Eligibility criteria

• 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.