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Chemoradiation Versus Oesophagectomy for Locally

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Chemoradiation Versus Oesophagectomy for Locally Jia et al. Trials (2019) 20:206 https://doi.org/10.1186/s13063-019-3316-5 STUDY PROTOCOL Open Access Chemoradiation versus oesophagectomy for locally advanced oesophageal cancer in Chinese patients: study protocol for a randomised controlled trial Ruinuo Jia1,2, Weijiao Yin1, Shuoguo Li1, Ruonan Li1, Junqiang Yang1, Tanyou Shan1, Dan Zhou1, Wei Wang1, Lixin Wan3, Fuyou Zhou4 and Shegan Gao1* 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: Oesophageal squamous cell carcinoma, Definitive chemoradiotherapy, Oesophagectomy * Correspondence: [email protected] 1The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, 24 Jinghua Road, Luoyang 471003, China Full list of author information is available at the end of the article © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Jia et al. Trials (2019) 20:206 Page 2 of 8 Background the two study arms, a superior 5-year OS was found in the Oesophageal cancer (EC) is the eighth most common CRT arm, but with no statistical significance [13, 14]. cancer worldwide and the sixth leading cause of In recent studies, both oxaliplatin and capecitabine cancer-related death [1]. In 2012, 456,000 EC cases oc- have been shown to be at least equivalent to cisplatin curred, and 400,000 people died from EC worldwide. It’s and 5-FU in the treatment of advanced upper gastro- remarkable that almost half of them came from China, intestinal (GI) cancer or EC. Also, they can be given as a with 223,000 EC cases and 197,000 death cases in 2012. convenient 2-h infusion and an oral administration, and Both the highest incidence and highest mortality, 379/ they have a more favourable toxicity profile compared to 100,000 and 150/100,000, respectively, were in Henan, cisplatin and 5-FU [15, 16]. Based on these previous China (including Linzhou, Anyang and Huixian cities). findings, this randomised, open-label, multicentre clin- Additionally, EC is the fourth most deadly cancer among ical trial aims to compare outcomes in Chinese patients men in China; it is responsible for 9.8% of all cancer with locally advanced resectable oesophageal squamous deaths annually [2]. cell cancer (ESCC) who have received either NCRT plus Worldwide, approximately half of these patients surgery or DCRT. The primary endpoints will be 2-year/ present with locally advanced disease [3]. Radical oeso- 5-year OS, and the secondary endpoints will be 2-year/ phagectomy remains the most popular treatment for this 5-year progression-free survival (PFS), treatment-related disease, but the long-term survival is still barely satisfac- adverse events (AEs) and the patients’ quality of life tory [4, 5]. The mortality in the perioperative period is (QoL). Additionally, in the subgroup analysis of CRT, we approximately 5% at renowned centres. The 5-year sur- will investigate the effect and AEs between the different vival rate in patients with oesophageal carcinoma treated chemotherapy regimens: Xelox (capecitabine + oxalipla- by surgery alone is just 10–20% [6]. Numerous clinical tin), PF (cisplatin + 5-FU) and single capecitabine. This studies in past decades have used adjuvant or neoadju- is the first head-to-head clinical trial to compare CRT vant chemotherapy and radiotherapy as a tool to im- with radical operation in Chinese mainland people with prove the clinical outcome of surgery [7]. However, the locally advanced ESCC. results from prospective randomised trials on neoadju- vant radiotherapy or chemotherapy alone were not satis- Methods/design factory [8]. There was no survival benefit associated with Study design these approaches [9]. A multicentre, open, prospective, randomised controlled Concurrent chemoradiotherapy (CRT) as a neoadju- trial will be conducted that includes three regional hos- vant therapy has preferable clinical efficacy and has be- pitals in Henan, which is the area with the highest inci- come the standard treatment for local advanced EC with dence of ESCC in the world, including the First – recognised guidelines [10 12]. Compared with chemo- Affiliated Hospital of Henan University of Science and therapy or radiation alone, CRT has outstanding advan- Technology (HUST), Anyang Tumour Hospital of tages. Not only does it achieve a higher rate of complete HUST and Nanyang Centre Hospital. A total population pathologic regression of oesophageal tumours, but it is of 216 × 105 is served by these three hospitals. The trial also associated with a significant survival benefit [12]. A flow chart is shown in Fig. 1. The Standard Protocol complete tumour response was frequently observed after Items: Recommendations for Interventional Trials neoadjuvant CRT (NCRT), and this has prompted inves- (SPIRIT) checklist is provided in Additional file 1. tigations on the role of definitive concurrent chemora- diotherapy (DCRT) in locally advanced oesophageal carcinoma. However, most of those studies came from Ethical approval western, developed countries, and the majority of pa- This study protocol was approved by the Ethics Com- tients had adenocarcinomas. Different cell pathologies of mittees of the First Affiliated Hospital of HUST, Anyang the tumours could influence the clinical outcome follow- Tumour Hospital of HUST and Nanyang Centre Hos- ing the same treatment strategy. In recent studies, neoad- pital. The study is performed in accordance with the juvant or adjuvant chemotherapy was associated with Declaration of Helsinki, and written informed consent survival benefits in patients suffering from adenocarcin- will be collected from each study participant prior to omas of the oesophagus. A prospective clinical study from enrolment. Hong Kong University investigated the efficacy of CRT (three-dimensional conformal radiation therapy (3DCRT) Study participants in combination with two cycles of 5-fluorouracil (5-FU) Setting and cisplatin) compared with surgery in oesophageal squa- The study will take place at the First Affiliated Hospital mous cell cancer. Though this trial had shown no signifi- of HUST, Anyang Tumour Hospital of HUST and cant difference in the 2-year overall survival (OS) between Nanyang Centre Hospital. Jia et al. Trials (2019) 20:206 Page 3 of 8 Fig. 1 Flow chart of the trial Patients Withdrawal criteria A total of 196 ESCC patients with T1bN + M0 or Patients will be withdrawn from the study if they with- T2-4aN0-2 M0 will be randomised to the CRT group or draw informed consent and decline to continue treat- the surgery group. ment or follow-up. Inclusion criteria Recruitment The inclusion criteria are as follows: Recruitment will be from cancer centres of the First Af- filiated Hospital of HUST, Anyang Tumour Hospital of 1. Age 18–75 years HUST and Nanyang Centre Hospital, Henan province, 2. Mainland Chinese China. Research staff will regularly check the inpatient - 3. Oesophageal squamous cell cancer confirmed by registry information system and identify any potentially histology eligible patients. They will liaise with an oncologist to 4. Tumour is resectable ensure
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