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Open Access 01-12-2019 | Esophageal Cancer | Study protocol

A multicenter phase III study comparing Simultaneous Integrated Boost (SIB) radiotherapy concurrent and consolidated with S-1 versus SIB alone in elderly patients with esophageal and esophagogastric cancer – the 3JECROG P-01 study protocol

Authors: Chen Li, Xiaomin Wang, Xin Wang, Chun Han, Ping Wang, Qingsong Pang, Junqiang Chen, Xinchen Sun, Lan Wang, Wencheng Zhang, Yu Lin, Xiaolin Ge, Zongmei Zhou, Wenjie Ni, Xiao Chang, Jun Liang, Lei Deng, Wenqing Wang, Yidian Zhao, Zefen Xiao

Published in: BMC Cancer | Issue 1/2019

Abstract

Background

The importance of definitive radiotherapy for elderly patients with esophageal and esophagogastric-junction cancer is pronounced. However, little is known in terms of the best way to combine radiotherapy with other treatment options. This study aims to compare the efficiency of SIB radiotherapy alone with SIB radiotherapy concurrent and consolidated with S-1 for elderly patients. Comprehensive geriatric assessment is also incorporated in the procedure of treatment.

Methods/design

The study is a two arm, open, randomized multicenter Phase III trial with patients over 70 years old with stage IIA-IVB (UICC 2002, IVB only with metastasis to supraclavicular or celiac lymph nodes) squamous cell carcinoma or adenocarcinoma of esophagus or gastroesophageal junction. A total of 300 patients will be randomized using a 1:1 allocation ratio stratified by disease stage and study site. Patients allocated to the SIB arm will receive definitive SIB radiotherapy (95%PTV/PGTV 50.4Gy/59.92Gy/28f) while those randomized to SIB + S-1 arm will receive definitive SIB radiotherapy concurrent and consolidated with S-1. The primary endpoint of the trial is 1-year overall survival. Secondary objectives include progression-free survival, recurrence-free survival (local-regional and distant), disease failure pattern, toxicity profile as well as quality of life. Besides, detailed radiotherapy protocol and quality assurance procedure have been incorporated into this trial.

Discussion

The proportion of elderly patients in esophageal cancer is now growing, but there is a lack of evidence in term of treatment standard for this group of patients, which is what we aim to obtain through this prospective phase III study.

Trial registration

clinicaltrials.gov NCT02979691. Registered November 22, 2016.

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Title: A multicenter phase III study comparing Simultaneous Integrated Boost (SIB) radiotherapy concurrent and consolidated with S-1 versus SIB alone in elderly patients with esophageal and esophagogastric cancer – the 3JECROG P-01 study protocol
Authors: Chen Li
Xiaomin Wang
Xin Wang
Chun Han
Ping Wang
Qingsong Pang
Junqiang Chen
Xinchen Sun
Lan Wang
Wencheng Zhang
Yu Lin
Xiaolin Ge
Zongmei Zhou
Wenjie Ni
Xiao Chang
Jun Liang
Lei Deng
Wenqing Wang
Yidian Zhao
Zefen Xiao
Publication date: 01-12-2019
Publisher: BioMed Central
Keywords: Esophageal Cancer
Esophageal Cancer
Radiotherapy
Geriatric Assessment
Cytostatic Therapy
Published in: BMC Cancer / Issue 1/2019
Electronic ISSN: 1471-2407
DOI: https://doi.org/10.1186/s12885-019-5544-1

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