Squamous Cell Esophageal Carcinoma Clinical Trial
Official title:
A Phase III, Multicenter Randomized Controlled Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery Versus Surgery for Locally Advanced Squamous Cell Esophageal Carcinoma
The primary objective is to compare neo-adjuvant chemoradiotherapy followed by surgery versus surgery, in terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell esophageal carcinoma.
Esophageal cancer (EC) is the eighth most common cancers in the world, with more than
480,000 new cases and 400,000 deaths occurred annually worldwide. In China, every year, no
matter new cases or deaths account for more than half of the world. Besides, over 90% of
Chinese patients have esophageal squamous cell carcinoma (ESCC).
Surgery is the main treatment of this disease, but the prognosis of patients with locally
advanced esophageal cancer is rather poor. As a result of surgery alone, the 5-year survival
rate of about 25% has not changed significantly in several decades.
Preoperative chemoradiotherapy followed by surgery seems to hopefully improve the survival
of EC. Nevertheless, the results of different studies were inconsistent. Recently, the CROSS
trial has demonstrated that preoperative chemoradiotherapy can significantly increased the
overall survival of patients with EC compared with surgery alone. It should be noticed that
only 84 cases(23%) of ESCC were enrolled in this trial with potential minimal follow-up of 2
years, which may be not perfect to evaluate the effect of this combined therapy for this
tumor type.
Up till now, vinorelbine has no indications for esophageal cancer, although, some studied
have reported its effect and feasibility to the therapy of EC. Vinorelbine has similar
mechanism with paclitaxel and docetaxel, which are recommended for the chemotherapy of EC by
NCCN. They are all classified as antimicrotubule agents, which cause mitotic arrest and
eventual cell death through inhibition of microtubule dynamics. In comparison with the
taxanes, vinorelbine has obvious advantage of few cardiac toxicity. This should be
beneficial to prevent cardiac side effects of chemoradiotherapy, especially for the middle
or lower thoracic EC, which account for over 70% of thoracic EC in China. For this group of
patients, radiotherapy can hardly avoid cardiac toxicity.
Based on our preliminary study, we have demonstrated the validity and safety of vinorelbine
and cisplatin-based neoadjuvant chemoradiotherapy.
We are to carry out a phased III clinical trial to investigate the effect of this
multidisciplinary therapy for the overall survival of patients with locally advanced ESCC.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05357846 -
PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)
|
Phase 3 | |
| Recruiting |
NCT02188615 -
Study of Neo-adjuvant Chemoradiotherapy Followed by Minimally Invasive Esophagectomy for Squamous Cell Esophageal Cancer
|
Phase 2 |