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)

Completed

Conditions: squamous cell carcinoma of the oral cavity
10027655
10019190

Registration Number: NL-OMON45143

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the total amount of activity in the tumor (in<br /><br>percentage). We consider a leakage of * of the injected activity from the tumor<br /><br>the maximum acceptable leakage. Therefore we consider this treatment feasible,<br /><br>if the detected activity in the tumor is more than two third of the injected<br /><br>activity.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include adverse events occurring between the time of<br /><br>administration until resolution of the adverse events, and determination of<br /><br>radioactivity and holmium content in a blood and urine sample after<br /><br>administration. Furthermore, the biodistribution of 166Ho-microspheres after<br /><br>intra-tumoural injection will be studied ex-vivo with micro CT and histology. </p><br>