Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Nasopharyngeal Carcinoma

Patients will be deemed eligible for inclusion if all the following criteria are met.

• Histologically confirmed local or locoregional recurrent or persistent NPC, [T1-2a, N1-2; M0] at least 3 months following a full course of irradiation
• Discrete tumour, less or equal to 15 mm in depth, which is endoscopically visible and accessible for unrestricted surface illumination using a nasopharyngeal applicator, with no bony invasion
• Patient is 18 - 69 years of age, and legally competent
• Patient has a ECOG performance status ≤2
• Patient is a man or a non-pregnant, non-lactating woman
• Patient, or his legally appointed representative, is able and willing to provide informed consent to participate in the study

Exclusion Criteria:

Patients will not be deemed eligible for inclusion if any of the following criteria apply.

• Elective surgery is planned for within 30 days of administration of Foscan®
• Patient has any disease, which is caused or exacerbated by light, including systemic lupus erythematosus, psoriasis, porphyria, actinic reticuloid or xeroderma pigmentosum
• Patient has been treated within the prior 30 days with a light-activated therapy or other medication that may render the patient photosensitive (e.g., psoralen ultraviolet A-range [PUVA], Accutane)
• Patient has received prior photodynamic therapy to the proposed treatment site within the prior 3 months
• Patient has co-existing ophthalmic disease, which is likely to require slit lamp examination within 30 days following Foscan® administration
• Patient has a known hypersensitivity to temoporfin, or any of the excipients, or to porphyrins
• Patient has a tumour known to be eroding into a major blood vessel in, or adjacent to, the proposed illumination site
• Patient is of childbearing potential and will not use adequate contraceptive protection. Patient should practice strict birth control (oestrogen-containing oral contraceptives or an intrauterine device) throughout the study. Only post-menopausal women (at least 2 years since the onset of the menopause) and women who have had a hysterectomy are exempt from the requirement to use birth control.
• Patient has received treatment with an experimental drug within the prior 30 days
• Patient has received radiotherapy to the head and neck region within the prior 3 months
• Patient is not willing or able to complete the visit requirements of this protocol or adhere to the instructions regarding light exposure