A multicenter prospective phase III clinical randomized study of simultaneous integrated boost intensity-modulated radiotherapy with or without concurrent chemotherapy in patients with esophageal cancer: 3JECROG P-02 study protocol

BMC Cancer

Xiaomin Wang¹  Yidian Zhao¹  Ling Li²  Tao Zhang³  Chen Li³  Nan Bi³  Wenyang Liu³  Jima Lv³  Yirui Zhai³  Lin-rui Gao³  Jianyang Wang³  Zefen Xiao³  Lei Deng³  Wenjie Ni³  Qinfu Feng³  Wei Deng³  Xin Wang³  Jun Liang³  Xiao Chang³  Zongmei Zhou³  Weiming Han³  Wenqing Wang³ 

[1] Department 4th of Radiation Oncology, Anyang Cancer Hospital, 455000, Anyang, China;Department of Oncology, Affiliated Tengzhou Central People’s Hospital of Jining Medical University, Jining Medical University, 277599, Tengzhou, China;Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 100021, Beijing, China;

关键词: Esophageal cancer;    Concurrent chemoradiotherapy;    Definitive chemoradiotherapy/radiotherapy;    Consolidated chemotherapy;    Simultaneous integrated boost;    Intensity-modulated radiotherapy;    Randomized controlled trial;   

DOI  :  10.1186/s12885-020-07387-y

来源: Springer

【 摘 要 】

BackgroundSince the development of three-dimensional conformal radiotherapy and intensity-modulated radiotherapy (IMRT), no prospective study has investigated whether concurrent chemoradiotherapy (SIB-IMRT with 60 Gy) remains superior to radiotherapy (SIB-IMRT) alone for unresectable esophageal cancer (EC). Furthermore, the optimal therapeutic regimen for patients who cannot tolerate concurrent chemoradiotherapy is unclear. We recently completed a phase I/II radiation dose-escalation trial using simultaneous integrated boost (SIB), elective nodal irradiation, and concurrent chemotherapy for unresectable EC. We now intend to conduct a prospective, phase III, randomized study of SIB-IMRT with or without concurrent chemotherapy. We aim to find a safe, practical, and effective therapeutic regimen to replace the conventional segmentation (1.8–2.0 Gy) treatment mode (radiotherapy ± chemotherapy) for unresectable EC.MethodsThis two-arm, open, randomized, multicenter, phase III trial will recruit esophageal squamous cell carcinoma patients (stage IIA–IVB [UICC 2002]; IVB only with metastasis to the supraclavicular or celiac lymph nodes). In all, 164 patients will be randomized using a 1:1 allocation ratio, and stratified by study site and disease stage, especially the extent of lymph node metastasis. Patients in the SIB arm will receive definitive SIB radiotherapy (95% planning target volume/planning gross tumor volume, 50.4 Gy/59.92 Gy/28 f, equivalent dose in 2-Gy fractions = 60.62 Gy). Patients in the SIB + concurrent chemotherapy arm will receive definitive SIB radiotherapy with weekly paclitaxel and a platinum-based drug (5–6 weeks). Four cycles of consolidated chemoradiotherapy will also be recommended. The primary objective is to compare the 1-year, 2-year, and 3-year overall survival of the SIB + chemotherapy group and SIB groups. Secondary objectives include progression-free survival, local recurrence-free rate, completion rate, and adverse events. Detailed radiotherapy protocol and quality-assurance procedures have been incorporated into this trial.DiscussionIn unresectable, locally advanced EC, a safe and effective total radiotherapy dose and reasonable segmentation doses are required for the clinical application of SIB-IMRT + two-drug chemotherapy. Whether this protocol will replace the standard treatment regimen will be prospectively investigated. The effects of SIB-IMRT in patients with poor physical condition who cannot tolerate definitive chemoradiotherapy will also be investigated.Trial registrationclinicaltrials.gov (NCT03308552, November 1, 2017).

【 授权许可】

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