BMC cancer · 2019
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.
Протокол клинического исследованияСравнительное исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Li Chen, Wang Xiaomin, Wang Xin, Han Chun, Wang Ping, Pang Qingsong, Chen Junqiang, Sun Xinchen, Wang Lan, Zhang Wencheng, Lin Yu, Ge Xiaolin, Zhou Zongmei, Ni Wenjie, Chang Xiao, Liang Jun, Deng Lei, Wang Wenqing, Zhao Yidian, Xiao Zefen
Аннотация
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.
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.
Предметные рубрики MeSH
AgedAged, 80 and overFemaleHumansMaleAdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellChemoradiotherapyDrug CombinationsEsophageal NeoplasmsEsophagogastric JunctionFluorouracilMulticenter Studies as TopicNeoplasm StagingOutcome Assessment, Health CareOxonic AcidProspective StudiesRadiotherapy, Intensity-ModulatedRandomized Controlled Trials as TopicStomach NeoplasmsTegafurClinical Trials, Phase III as Topic