Photodynamic therapy as palliative treatment for recurrent squamous cell carcinom of the head and neck regio

Conditions: Recurrent squamous cell carcinoma of the head and neck Region

Registration Number: EUCTR2004-004452-39-DK

Lead Sponsor: Christel B. Lajer, Dep. of Otolaryngology head and neck surgery, Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 50

Inclusion Criteria

Patients with recurrent squamous cell carcinoma unsuitable for curative intended surgery or radiotherapy
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Age < 18 years
·Porfyria or other diseases exacerbated by light.
·Hypersensitivity to temoporfin or to any of the excipients.
·Known allergy to porphyrins.
·Tumours known to be eroding into a major blood vessels in or adjacent to the illuminated site.
·Planned surgery within 30 days after treatment.
·Coexisting ophthalmic disease likely to require slit lamp examination within 30 days after treatment.
·Existing therapy with a photosensitizing agent.
·Patients incapable of understanding patient information and/or are unable to follow precautions against light exposure 30 days post treatment.
·Diabetes mellitus.
·Other known malignancies.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To examine the effect of PDT as palliative treatment in advanced cases of squamous cell carcinoma in the head and neck region. Furthermore to evaluate the feasibility of PET/CT as a measure of very early tumour response after PDT;Secondary Objective: To evaluate the treatments impact on Patients quality of life. <br>To find the optimal time for lightactivation after infusion of the photosesitizer (Foscan);Primary end point(s): Tumour response according to WHO<br>Survival<br>Life of quality score according to EORTC QLQ-C30 (version 2.0.) and EORTC QLQ-H&N35

Secondary Outcome Measures