Prospective, multicentre phase II study of de-escalation of primary chemoradiotherapy of squamous cell carcinoma of oropharynx (OPC) associated with human papilloma virus (HPV) - NaDeJ

VÝCHODOSLOVENSKÝ ONKOLOGICKÝ ÚSTAV, a.s.0 个研究点目标入组 120 人开始时间: 2019年9月16日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•Oropharyngeal squamous cell carcinoma
•Positivity of p16 by imunohistochemistry
•Clinical stage T1-T2, N1-N2c or T3, N2-N2c, UICC 8th edition without distant metastases
•The lifetime cumulative history of smoking cannot exceed 20 packages / years
•WHO status 0-1
•Age = 18 years
•Both genders
•Hemoglobin = 10 g/l
•Platelets =1 00x 10x9/l
•Neutrophils = 1,5 x 10x9/l
•Adequate renal functions enable one-week therapy of cisplatina
•Bilirubin, AST or ALT 3x upper limit of norm
•Negative pregnancy test
•Signed informed consent
•Slovak language
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Tumor in the oral cavity or in nasopharynx or in the hypopharynx or larynx if the p16 is also positive
•Tumor of unknown origin (p16 positivity too)
•Simultaneous tumors
•Patients with invasive malignancy (except non-melanoma skin cancer) and a history of tumor diagnosis less than 3 years
•Previous radiotherapy in the head and neck area to overlap the irradiated volume
•Unstable angina or congestive heart failure requiring hospitalization for the last 6 months
•Transmural myocardial infarction last 6 months
•Active infection requiring i.v. antibiotics at the time of registration
•Chronic obstructive bronchoplumonal disease with exacerbation or other respiratory disease requiring hospitalization or postponement of study treatment within 30 days of enrollment
•Hepatic insufficiency with clinical jaundice and impaired coagulation
•Active AIDS disease, but the protocol does not require HIV testing
•Previous allergic reaction to cisplatin

发起方

VÝCHODOSLOVENSKÝ ONKOLOGICKÝ ÚSTAV, a.s.