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Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy
Sponsor: Fujian Medical University Union Hospital
Summary
The primary objective is to compare surgery with postoperative radiotherapy (PORT) versus surgery, in terms of the overall survival time (OS) in Stage II or III squamous cell esophageal carcinoma with neoadjuvant chemoradiotherapy(nCRT).
Official title: Prospective Randomized Controlled Trial of Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
537
Start Date
2023-05-01
Completion Date
2029-01-01
Last Updated
2023-09-25
Healthy Volunteers
No
Conditions
Interventions
Neoadjuvant Radiotherapy Program:
Gross tumor volume (GTV) should include the primary tumor and involved regional lymph nodes as identified on pre-treatment diagnostic studies. Clinical target volume (CTV) is defined as the primary tumor plus 3cm expansion superiorly and inferiorly along the length of the esophagus and a 1cm radial expansion.The nodal CTV should be defined by a 0.5cm expansion from the nodal GTV.CTV should also include coverage the nodal region(s) in which the involved lymph node(s). A total dose of 45 Gy in 25 fractions is delivered 5 days per week on workdays with intensity modulated radiotherapy (IMRT).
Neoadjuvant chemotherapy Program
Chemotherapy is delivered concomitantly and composed of two cycles of Docetaxel 60mg per square meter of body-surface area and cisplatin 75mg per square meter of body-surface area every 21 days at the intervals of neoadjuvant radiotherapy.
Esophagectomy program:
Patients receive esophagectomy in 4-6 weeks after neoadjuvant neoadjuvant chemotherapy
Postoperative radiotherapy program
A total dose of 18 Gy in10 fractions is delivered 5 days per week on workdays with IMRT.
Locations (1)
Fujian Medical University Union Hospital
Fuzhou, Fujian, China