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).
Esophageal squamous cell carcinoma (ESCC) is a common type of esophageal carcinoma in China, which is characterized by rapid development and fatal prognosis in most patients. Neoadjuvant chemoradiotherapy (nCRT) has been explored for many years in western countries and Japan, and proved to get survival benefit, especially for locally advanced esophageal cancer. However, the recurrence is the major cause of treatment failure in patients with ESCC. Our hypothesis is that inadequate radiation dose leads to recurrence of ESCC with nCRT and PORT lower recurrence rate and improved OS. As is known, there are no any studies concentrating on PORT in ESCC with nCRT. Patients are randomly assigned to PORT (Group A) or without PORT (Group B) with a 1:1 allocation ratio. The primary outcome is OS assessed with a minimum follow-up of 60 months. Secondary outcomes are progression-free survival (PFS), recurrence-free survival (RFS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
537
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).
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.
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGoverall survival
The length of time from enrollment until the time of death
Time frame: From enrollment to 5 years after the end of treatment
disease free survival
The length of time from enrollment until the time of progression of disease
Time frame: From enrollment to 5 years after the end of treatment
local recurrence rate
The percent of the patient with local recurrence
Time frame: From enrollment to 5 years after the end of treatment
Side effects
adverse events according to NCI CTCAE 4.0 criteria
Time frame: From enrollment to 12 weeks after end of the treatment
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Patients receive esophagectomy in 4-6 weeks after neoadjuvant neoadjuvant chemotherapy
A total dose of 18 Gy in10 fractions is delivered 5 days per week on workdays with IMRT.