JCOG1212: Dose finding and confirmatory trial of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for patients with locally advanced maxillary sinus cancer - RADPLAT-MSC

Homma Akihiro0 个研究点目标入组 127 人开始时间: 2019年1月18日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) primary lesion located at maxillary sinus
•2) histologically proven squamous cell carcinoma
•3) clinical stage T4aN0M0 or T4bN0M0
•4) no severe carotid stenosis evaluated by ultrasonography
•5) age between 20 and 75 years old (dose finding phase), age between 20 and 80 years old (confirmatory phase)
•6) ECOG performance status of 0 or 1
•7) no prior therapy for maxillary sinus cancer
•8) no prior radiation therapy to the head and neck, and the brain
•9) no prior chemotherapy for any other malignancies
•10) sufficient organ function
•11) normal electrocardiogram
•12) suitable for angiography
•13) satisfy normal tissue radiation dose constraints such as at least ipsilateral eyeball and optic nerve, spinal cord, brainstem, and chiasma
•14) written informed consent

•1) simultaneous or metachronous (within 5 years) double cancers except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers
•2) active bacterial or fungous infection
•3) body temperature >= 38 degrees Celsius
•4) women during pregnancy or breastfeeding
•5) psychosis
•6) requiring systemic steroids medication or immunosuppressant medication
•7) diabetes mellitus poorly controlled
•8) poorly controlled hypertension
•9) angina pectoris attack within 3 weeks or myocardial infarction within 6 months
•10) positive HBs antigen

发起方

Homma Akihiro