Abstract
BackgroundThe 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/designThe 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.DiscussionThe 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 registrationclinicaltrials.govNCT02979691. Registered November 22, 2016.
Highlights
The importance of definitive radiotherapy for elderly patients with esophageal and esophagogastricjunction cancer is pronounced
The proportion of elderly patients in esophageal cancer is 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
We propose a prospective phase III clinical trial to improve definitive chemoradiotherapy (dCRT) regimen for elderly patients in three aspects: First, S-1, a single chemotherapeutic drug will be used instead of the conventional two-drug chemotherapy regimen to improve therapeutic effect while maintaining the rate of toxicities at a relatively low level
Summary
The importance of definitive radiotherapy for elderly patients with esophageal and esophagogastricjunction cancer is pronounced. The management of elderly patients with EC/EGJC is still challenging as their relative poor physical conditions impose great limitations on their treatment. They are considered ineligible for esophagectomy, the major component of treatment norm for patients with resectable EC/EGJC, because of the high rates of postoperative morbidity and mortality (especially those received preoperative chemoradiation) [3, 4]. The dual-drug intravenous chemotherapy regimen (fluorouracil/capecitabine + platinum drugs) recommended by National Comprehensive Cancer Network (NCCN) [5] and European Society for Medical Oncology (ESMO) [6] may bring severe acute and late toxic effects and poor compliance rate in elderly population. A modified dCRT regimen specific to the elderly is in great demand
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