Feasibility of holmium-166 microspheres for selective intra-tumoural treatment in head and neck cancer: biodistribution and safety in patients with malignancy of the oral cavity (the HIT study) - HIT study

niversitair Medisch Centrum Utrecht0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•1. Patients must have given written informed consent.
•2. Aged 18 years and over.
•3. Confirmed histological diagnosis of squamous cell carcinoma of the oral cavity.
•4. TNM-stage T1-2 Nx M0.
•5. Eigible for local surgery with curative intent.
•6. World Health Organization (WHO) Performance status 0-2.

•1. Previous oncologic surgery and/or external beam radiation therapy on the tongue and oral floor.
•2. Major surgery (oral cavity) within the past 4 weeks or incompletely healed surgical incisions before starting study therapy.
•3. Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 4.03) grade 2 from previous anti-cancer therapy.
•4. Pregnancy or nursing (women of child-bearing potential).
•5. Patients suffering from psychic disorders that make a comprehensive judgment impossible, such as psychosis, hallucinations and/or depression.
•6. Previous enrolment in the present study.

发起方

niversitair Medisch Centrum Utrecht