Overview

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

Status:
Unknown status
Trial end date:
2011-10-01
Target enrollment:
0
Participant gender:
All
Summary
Objectives: Primary objective - 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. The primary endpoint is complete tumour response at 6 months. Secondary objective: - To determine the response rates, e.g. presence of tumour on endoscopy, time to progression and overall survival in patients treated with Foscan-PDT compared with brachytherapy - To determine the quality of life, as derived from the University of Washington Quality of Life questionnaire in patients treated with Foscan-PDT compared with brachytherapy - To evaluate the safety of Foscan-PDT compared with brachytherapy in terms of adverse events and serious adverse events.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ministry of Health, Malaysia
Treatments:
Temoporfin
Criteria
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