A Phase II, Randomized Controlled Trial of Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Recurrent or Persistent Nasopharyngeal Carcinoma
This is a multi-centre, randomized, controlled Phase II study assessing the use of
Foscan®-mediated photodynamic therapy versus Brachytherapy in patients with recurrent or
persistent nasopharyngeal carcinoma.
The starting point for the PDT arm of the study will be the parameters recommended for the
treatment of patients with squamous cell carcinoma of the head and neck. These parameters
(drug dose, 0.1 mg/kg Foscan®; drug-light interval, 48 hours; light dose, 20 J/cm2 at 50 mW)
have been shown to be effective in a limited number of treatments performed in patients with
Patients will be evaluated on a regular basis for 12 weeks following treatment. Patients
with a persistent tumour (confirmed histologically, where clinically possible) at 12 weeks
following treatment, and in whom adequate clinical assessment of tumour response is
possible, may be retreated with Foscan®. A maximum of two Foscan®-PDT treatments may
administered to a single patient. Patients will be followed up for up to 24 months
following the final Foscan®-PDT treatment.
Study population Any patient with recurrent or persistent nasopharyngeal carcinoma, at least
3 months following a full course of irradiation, is eligible for assessment for enrolment in
the study provided that the tumour is less or equal to 15 mm in depth and is accessible for
unrestricted illumination using a nasopharyngeal applicator. Diagnosis of cancer will, in
the first instance, be made by clinical inspection of the site. The diagnosis must then be
confirmed histologically. All patients will have a full assessment and diagnostic workup in
accordance with usual departmental practices, including a CT scan of the skull base and
The study centres will keep a log of all patients screened or evaluated for inclusion into
the study and will document the reasons why patients were not included or selected.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary endpoint: To determine the efficacy of Foscan-PDT compared with Brachytherapy for recurrent or persistent NPC, as determined by macroscopic clinical examination, CT scan and biopsy.
Yoke Yeow Yap, MD
University Putra Malaysia
Malaysia: Ministry of Health