Brief Title
Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Nasopharyngeal Carcinoma
Official Title
A Phase II, Randomized Controlled Trial of Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Recurrent or Persistent Nasopharyngeal Carcinoma
Brief 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.
Detailed Description
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
nasopharyngeal carcinoma.
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 neck.
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
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.
Secondary Outcome
To determine the response rates
Condition
Nasopharyngeal Carcinoma
Intervention
FOSCAN
Study Arms / Comparison Groups
Nasopharyngeal Carcinoma
Description: A: Experimental B: Active Comparator
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
66
Start Date
January 2009
Completion Date
October 2011
Primary Completion Date
September 2011
Eligibility 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
Gender
All
Ages
18 Years - 69 Years
Accepts Healthy Volunteers
No
Contacts
Yoke Yeow Yap, MD, 0123056912, [email protected]
Location Countries
Malaysia
Location Countries
Malaysia
Administrative Informations
NCT ID
NCT01086488
Organization ID
CT 08-03
Secondary IDs
major research grant
Study Sponsor
Ministry of Health, Malaysia
Study Sponsor
Yoke Yeow Yap, MD, Principal Investigator, University Putra Malaysia
Verification Date
July 2011