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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004452-39-DK

Enrollment

Registered

2004-12-08

Start date

2005-01-24

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent squamous cell carcinoma of the head and neck Region

Interventions

Trade Name: Foscan Product Name: Foscan (Temoporfin) Pharmaceutical Form: Intravenous infusion INN or Proposed INN: meta-tetrahydroxy chlorin Other descriptive name: temoporfin Concentration unit: mg/

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. To find the optimal time for lightactivation after infusion of the photosesitizer (Foscan);Primary end point(s): Tumour response according to WHO Survival Life of quality score according to EORTC QLQ-C30 (version 2.0.) and EORTC QLQ-H&N35	—

Measure

Time frame

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. To find the optimal time for lightactivation after infusion of the photosesitizer (Foscan);Primary end point(s): Tumour response according to WHO Survival Life of quality score according to EORTC QLQ-C30 (version 2.0.) and EORTC QLQ-H&N35

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026