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Clinical Trials/EUCTR2004-004452-39-DK
EUCTR2004-004452-39-DK
Active, not recruiting
Not Applicable

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

Christel B. Lajer, Dep. of Otolaryngology head and neck surgery, Rigshospitalet0 sites50 target enrollmentStarted: December 8, 2004Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Christel B. Lajer, Dep. of Otolaryngology head and neck surgery, Rigshospitalet
Enrollment
50

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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.

Investigators

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

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