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

Inclusion Criteria:

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