A prospective pilot study on the safety and feasibility of sentinel node biopsy in the neck management of conventionally assessed lymph node negative sinonasal squamous cell carcinoma - SentiNose Pilot

niversitätsklinikum Ulm, Kliniken am oberen Eselsberg0 个研究点目标入组 25 人开始时间: 2020年11月13日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Histologically proven malignancy of the nasal vestibulum and the sinonasal tract; T1-3, N0, M0; squamous cell carcinoma
•Primary tumor must be resectable endoscopically or via limited open approach without changing the facial appearance
•Written and signed informed consent
•ECOG PS =2, Karnofsky PS = 60 %
•Age = 18
•Curative treatment intent

•Prior head and neck malignancy
•Entity other than squamous cell carcinoma
•Clinically suspected lymph node or distant metastases
•Serious co-morbidity, e.g. high-grade carotid artery stenosis, congestive heart failure NYHA grade 3 and 4, liver cirrhosis CHILD C
•Hemoglobin level < 9.5 g/dl
•Pregnancy or lactation
•Prior treatment of the neck of any cause
•Concurrent treatment with experimental drugs or participation in another clinical trial of any kind within 30 days prior to study screening
•Social situations that limit compliance with study requirements or patients with an unstable condition (e.g., psychiatric disorder, a recent history of drug or alcohol abuse, interfering with study compliance, within 6 months prior to screening) or otherwise thought to be unreliable or incapable of complying with the requirements of the protocol
•Patients institutionalized by official means or court order

发起方

niversitätsklinikum Ulm, Kliniken am oberen Eselsberg