Chemoradiation versus oesophagectomy for locally advanced oesophageal cancer in Chinese patients: study protocol for a randomised controlled trial

Ruinuo Jia, Weijiao Yin, Shuoguo Li, Ruonan Li, Junqiang Yang, Tanyou Shan, Dan Zhou, Wei Wang, Lixin Wan, Fuyou Zhou, Shegan Gao, Ruinuo Jia, Weijiao Yin, Shuoguo Li, Ruonan Li, Junqiang Yang, Tanyou Shan, Dan Zhou, Wei Wang, Lixin Wan, Fuyou Zhou, Shegan Gao

Abstract

Background: Surgery is the gold standard treatment for local advanced disease, while definitive concurrent chemoradiotherapy (DCRT) is recommended for those who are medically unable to tolerate major surgery or medically fit patients who decline surgery. The primary aim of this trial is to compare the outcomes in Chinese patients with oesophageal squamous cell cancer with locally advanced resectable disease who have received either surgery or DCRT.

Methods/design: One hundred ninety-six patients with T1bN + M0 or T2-4aN0-2 M0 oesophageal squamous cell cancer will be randomised to the DCRT group or the surgery group. In the DCRT group, patients will be given intensity-modulated radiation therapy (IMRT) with 50 Gy/25 fractions and basic chemotherapy with 5-fluorouracil regimens. In the surgery group, patients will receive neoadjuvant chemoradiotherapy (NCRT) and standard oesophagectomy. Five years of follow-up will be scheduled for patients. The primary endpoints are 2-year/5-year overall survival; the secondary endpoints are 2-year/5-year progression-free survival, treatment-related adverse events and the patients' quality of life. The main evaluation methods include oesophagoscopy, endoscopic ultrasonography and biopsy, oesophageal barium meal, computed tomography, positron emission tomography-computed tomography, blood tests and questionnaires.

Discussion: The preponderant oesophageal cancer pathology type is dramatically different in western Caucasian and Asian oesophageal cancer patients: Caucasian patients present with 80% adenocarcinomas, and Asians patients present with 95% squamous cell carcinomas. This phenomenon needs more in-depth studies to elucidate the differences in these populations. Based on the results of this study, we will show whether DCRT will benefit patients more than oesophagectomy. This study will contribute more evidence to the management of oesophageal squamous cell cancer.

Trial registration: ClinicalTrials.gov, NCT02972372 . Registered on 26 November 2016.

Keywords: Definitive chemoradiotherapy; Oesophageal squamous cell carcinoma; Oesophagectomy.

Conflict of interest statement

Ethics approval and consent to participate

Ethics: This study has been approved by the Ethics Committee of the First Affiliated Hospital of Henan University of Science and Technology. The approval number is 2016110201.

Informed consent: Written informed consent will be collected from each study participant prior to enrolment.

Consent for publication

The authors certify that they will obtain all the appropriate patient consent forms. With the form the patients will give their consent for their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published, and due effort will be made to conceal their identity, but anonymity cannot be guaranteed.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of the trial
Fig. 2
Fig. 2
Schedule of enrolment, interventions and assessments

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