Actively Recruiting
Randomized Study Comparing Surgery With and Without Postoperative Radiotherapy for Stage II-III Thoracic Esophageal Squamous Cell Carcinoma After Neoadjuvant Chemoradiotherapy
Led by Fujian Medical University Union Hospital · Updated on 2023-09-25
537
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the effects of adding postoperative radiotherapy PORT to surgery for patients with Stage II or III thoracic esophageal squamous cell carcinoma who have already received neoadjuvant chemoradiotherapy nCRT. This study aims to compare overall survival time between patients treated with surgery plus PORT and those treated with surgery alone. Recurrence is a major challenge in treating this cancer, and the study evaluates whether PORT can reduce recurrence and improve survival. Patients are randomly assigned to two groups to assess these outcomes with a follow-up of at least 60 months. Participants in Group A receive a combination of neoadjuvant radiotherapy and chemotherapy, followed by esophagectomy surgery and then postoperative radiotherapy using intensity modulated radiotherapy IMRT to deliver a total dose of 18 Gy in 10 fractions. Group B receives the same neoadjuvant radiotherapy and chemotherapy plus esophagectomy but without the postoperative radiotherapy. The neoadjuvant radiotherapy involves 45 Gy in 25 fractions delivered 5 days per week, with chemotherapy given as two cycles of Docetaxel and Cisplatin every 21 days. Surgery is performed 4-6 weeks after chemotherapy. During the study, participants undergo assessments for overall survival as the primary outcome, with secondary outcomes including disease-free survival, local recurrence rate, and side effects monitored up to 12 weeks after treatment. The trial includes detailed evaluations of treatment effects over a minimum of five years post-treatment. Participants provide informed consent and are monitored for safety and treatment response throughout the study period.
CONDITIONS
Brief Title
Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed squamous cell carcinoma of the esophagus
- Tumor located in the thoracic esophagus
- Pre-treatment stage II or III (AJCC/UICC 8th Edition)
- Male or non-pregnant female
- Age between 18 and 65 years
- ECOG performance status of 0-1 or Karnofsky score of 70 or more
- Adequate bone marrow function (WBC ≥4x10^9/L, Neutrophil ≥1.5x10^9/L, Hemoglobin ≥90 g/L, Platelets ≥100x10^9/L)
- Adequate liver function (bilirubin, AST, ALT ≤2x upper limit of normal)
- Adequate renal function (serum creatinine ≤1.5x upper limit of normal)
- Able to provide informed consent and comply with the study
You will not qualify if you...
- Non-squamous cell carcinoma histology
- Advanced inoperable or metastatic esophageal cancer
- Previous or current other malignant disease
- Significant medical conditions limiting therapy tolerance, such as cardiac disease
- Age over 65 years
- Pregnant or lactating females or those refusing contraception
- Uncontrolled seizures or psychiatric disorders affecting behavior
- Refusal of surgery after neoadjuvant chemotherapy
- Considered unsuitable for enrollment by investigators
Research Team
B
Benhua Xu, doctor
J
Jianyuan Song, doctor
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