Esophageal cancer is one of the most common cancers worldwide, while more than half new cases and deaths occurred in China. Surgery is the main curative treatment for this disease, the 5-year survival of EC remains poor, since most diseases are diagnosed at advanced stages. In last decades, several large clinical trials and meta-analyses have demonstrated that neo-adjuvant chemoradiotherapy followed by surgery can significantly increase the overall survival of patients with EC compared with surgery alone, while no effect of nCRT was apparent on postoperative health-related quality of life . However, the optimal radiation dose and surgery timing are still unknown. The investigators hypothesize that patients who receive higher dose (50.4Gy/28F) of neoadjuvant chemoradiation will have better pathologic response and progress-free survival compared to lower dose (41.4Gy/23F) of chemoradiation followed by surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
147
50.4Gy/28F radiation and concurrent chemotherapy with paclitaxel plus CBP used weekly
41.4Gy/23F radiation and concurrent chemotherapy with paclitaxel plus CBP used weekly
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Progression free survival
Time from randomization to tumor progression or any deaths
Time frame: 2 year
R0 resection rate in each arm
no cancer cells seen microscopically at the resection margin
Time frame: analysis is completed 4 weeks after surgery
Complete pathological response rate
using the Chirieac grading system
Time frame: analysis is completed 4 weeks after surgery
Postoperative complications in each study arm
According to the NCI CTC3.0
Time frame: 30 and 90 days after surgery
Treatment failure pattern
including local recurrence or distant metastasis or both
Time frame: 2 year
Overall survival
by intention to treat and per protocol analyses in each study arm
Time frame: 5 year
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