Abstract
BackgroundNeoadjuvant therapy plus oesophagectomy has been accepted as the standard treatment for patients with potentially curable locally advanced oesophageal cancer. No completed randomized controlled trial (RCT) has directly compared neoadjuvant chemotherapy and neoadjuvant chemoradiation in patients with oesophageal squamous cell carcinoma (ESCC). The aim of the current RCT is to investigate the impact of neoadjuvant chemotherapy plus surgery and neoadjuvant chemoradiotherapy plus surgery on overall survival for patients with resectable locally advanced ESCC.MethodsThis open label, single-centre, phase III RCT randomized patients (cT2-T4aN + M0 and cT3-4aN0M0) in a 1:1 fashion to receive either the CROSS regimen (paclitaxel 50 mg/m2; carboplatin (area under the curve = 2), q1w, 5 cycles; and concurrent radiotherapy, 41.4 Gy/23 F, over 5 weeks) or neoadjuvant chemotherapy (paclitaxel 175 mg/m2; and cisplatin 75 mg/m2, q21d, 2 cycles). Assuming a 12% 5-year overall survival difference in favour of the CROSS regimen, 80% power with a two-sided alpha level of 0.05 and a 5% dropout each year for an estimated 3 years enrolment, the power calculation requires 456 patients to be recruited (228 in each group). The primary endpoint is 5-year overall survival, with a minimum 5-year follow-up. The secondary endpoints include 5-year disease-free survival, toxicity, pathological complete response rate, postoperative complications, postoperative mortality and quality of life. A biobank of pre-treatment and resected tumour tissue will be built for translational research in the future.DiscussionThis RCT directly compares a neoadjuvant chemotherapy regimen with a standard CROSS regimen in terms of overall survival for patients with locally advanced ESCC. The results of this RCT will provide an answer for the controversy regarding the survival benefits between the two treatment strategies.Trial registrationNCT04138212, date of registration: October 24, 2019.
Highlights
Neoadjuvant therapy plus oesophagectomy has been accepted as the standard treatment for patients with potentially curable locally advanced oesophageal cancer
Surgery alone is often accompanied by high recurrence and metastasis rates in patients with locally advanced oesophageal cancer, and this has brought about a shift in the management strategy from locoregional therapy alone to multimodality regimens [2]
In large parts of the Western world, neoadjuvant chemoradiotherapy plus surgery has been adopted as a standard treatment for patients with locally advanced oesophageal cancer based on the CROSS study [5]
Summary
Neoadjuvant therapy plus oesophagectomy has been accepted as the standard treatment for patients with potentially curable locally advanced oesophageal cancer. The aim of the current RCT is to investigate the impact of neoadjuvant chemotherapy plus surgery and neoadjuvant chemoradiotherapy plus surgery on overall survival for patients with resectable locally advanced ESCC. Surgery alone is often accompanied by high recurrence and metastasis rates in patients with locally advanced oesophageal cancer, and this has brought about a shift in the management strategy from locoregional therapy alone to multimodality regimens [2]. In large parts of the Western world, neoadjuvant chemoradiotherapy (nCRT) plus surgery has been adopted as a standard treatment for patients with locally advanced oesophageal cancer based on the CROSS study [5]. Some countries in Asia, especially Japan, advocate the use of neoadjuvant chemotherapy (nCT) as a standard treatment based on the JCOG9907 study [6]
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