Adjuvant chemotherapy for esophageal cancer after surgery
A Prospective, Randomized Controlled Clinical Trial of Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma
This study is testing if giving chemotherapy after surgery helps people with esophageal cancer live longer and stay cancer-free compared to just monitoring them without treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 232 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04174079 on ClinicalTrials.gov |
What this trial studies
This study involves patients with thoracic esophageal squamous cell carcinoma who have undergone total two-field lymph node dissection. Participants are randomly assigned to receive either adjuvant chemotherapy with docetaxel and nedaplatin or to be monitored postoperatively without chemotherapy. The primary outcomes being measured are the 3-year progression-free survival and 5-year overall survival rates between the two groups. The study aims to determine the effectiveness of adjuvant chemotherapy in improving survival outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with T≥3 or N≥1 thoracic esophageal squamous cell carcinoma who have undergone radical surgical resection and total two-field lymph node dissection.
Not a fit: Patients who have received neoadjuvant therapy prior to surgery or those with serious postoperative complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve survival rates for patients with thoracic esophageal squamous cell carcinoma after surgery.
How similar studies have performed: Other studies have shown promising results with adjuvant chemotherapy in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Uniersity Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Peng Lin, professor
- Email: linpeng@sysucc.org.cn
- Phone: +86-20-87343314
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.