Esophageal Neoplasms Clinical Trial
Official title:
Prospective, Non-randomised Phase Ⅱ Study of Simultaneous Integrated Boost Radiotherapy and Concurrent Nimotuzumab or Chemotherapy for Locally Advanced Esophageal Carcinoma
This prospective, non-randomized phase II study aims to compare radiotherapy and concurrent nimotuzumab with concurrent chemoradiotherapy to obtain a non-inferior pCR rate and pathological lymph node metastases rate in premise of lower toxicities in locally advanced esophageal cancer.
In the era of IMRT and concurrent chemoradiotherapy, the 5-year overall survival of
esophageal cancer increase from 10% to about 20%-40%, recurrence rate decrease from 80% to
50%-60%, and local recurrence remains to be the most important type of failure. What called
for is to enhance local control without increasing toxicity to improve survival. The
investigators have found effective and safe regimen of simultaneously integrated boost
radiotherapy in previous study, which can achieve high dose in tumor area with avoid of
normal tissues. However, a recent prospective study reported that neoadjuvant
chemoradiotherapy resulted in much higher toxicities compares to neoadjuvant chemotherapy
(46% vs. 15%, p= 0.04). Although chemoradiotherapy reached a higher pCR rate (28% vs. 9%,
p=0.002), patients did not differ in survival in two groups.
Nimotuzumab is an humanized monoclonal antibody against EGFR. Radiotherapy combines
Nimotuzumab reveals synergistic effect in head and neck cancers with lower toxicities as
compared to concurrent chemoradiotherapy. Our previous study showed that EGFR expression rate
were similar in esophageal cancer and head and neck cancers. Based on above results, the
investigators design this study which aims to obtain a non-inferior pCR rate and pathological
lymph node metastases rate in premise of lower toxicities.
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