The purpose of this study is to evaluate the outcomes of neoadjuvant chemoradiotherapy versus neoadjuvant chemotherapy followed by minimally invasive esophagectomy on patients with locally advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0).
It is a prospective randomized phase III clinical trial sponsored by Shanghai Zhongshan Hospital with other eight hospitals in China participating in. 264 patients with locally advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0) are recruited and randomly assigned into the neoadjuvant chemoradiotherapy group (NCRT group) and the neoadjuvant chemotherapy group (NCT group) according to the proportion of 1:1.The safety,efficacy of protocols and prognosis of patients are compared between the two regimens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
264
Before surgery, patients in this group receive neoadjuvant chemoradiotherapy. A total dose of 40 Gy is delivered in 20 fractions (5 fractions per week) for 4 weeks. Chemotherapy is delivered concomitantly and composed of four cycles of paclitaxel 50mg per square meter of body-surface area and cisplatin 25mg per square meter of body-surface area weekly at the intervals of radiotherapy. After neoadjuvant therapy of 4-8 weeks, minimally invasive esophagectomy is performed.
Before surgery, patients in this group receive neoadjuvant chemotherapy. Chemotherapy is delivered and composed of two cycles of paclitaxel 135mg per square meter of body-surface area and cisplatin 75mg per square meter of body-surface area every 4 weeks. After neoadjuvant therapy of 4-8 weeks, minimally invasive esophagectomy is performed.
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Overall survival(OS)
Time frame: Up to the date of death of any causes since the date of randomization, up to 36 months
Progression-free survival(PFS)
Disease recurrence is defined as locoregional (esophageal bed or anastomotic or regional lymph nodes) or metastatic (supraclavicular lymph nodes or distant organs).
Time frame: Up to the date of disease recurrence since the date of randomization, up to 36 months
Pathological response rate(pCR)
The resected specimen following neo-adjuvant treatment are assessed by using standardised work up of the resection specimen in the pathology department and standardised histological criteria for tumour regression grading. The degree of histomorphologic regression is clarified into four categories as follows: grade 1, no evidence of vital residual tumor cells (pathological complete response); grade 2, less than 10% vital residual tumor cells; grade 3, 10 to 50%; and grade 4, more than 50%.
Time frame: Up to the date of pathological reports obtained since the date of randomization, up to 12 months
R0 resection rate
No vital tumor is presented at the proximal, distal, or circumferential resection margin, it is considered to be R0 resection. If a vital tumor is shown at 1 mm or less from the proximal, distal, or circumferential resection margin, it is considered to be microscopically positive (R1).
Time frame: Up to the date of pathological reports obtained since the date of randomization, up to 12 months
Positive lymph nodes' number
According to pathological reports, record the number of positive lymph nodes
Time frame: Up to the date of pathological reports obtained since the date of randomization, up to 12 months
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After neoadjuvant therapy, patients in groups receive minimally invasive esophagectomy
Treatment related complications
Number and severity of adverse events that are related to treatment of each patients, and hospital readmission.
Time frame: Up to 1 month after surgery since the data of randomization, up to 13 months
Quality of life(QOL)
QOL is respectively evaluated at randomization and 1 month, 3 month, 6 month and yearly after surgery among patients by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30) and EORTC QLQ-OES18
Time frame: Up to the end of follow-up since the data of surgery, up to 36 months
Recurrence-free survival (RFS)
RFS is defined in resected patients who achieved an R0 or R1 resection as the time interval from surgery to the date of first recurrence (local, regional or distant) or death, whichever comes first.
Time frame: Up to the date of disease recurrence since the date of surgery, up to 36 months