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

Nasopharyngeal Carcinoma Clinical Trial

— FOSCAN  

Official title:

A Phase II, Randomized Controlled Trial of Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Recurrent or Persistent Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01086488
• Other study ID #: CT 08-03
• Secondary ID: major research g
• Status: Recruiting
• Phase: Phase 2
• First received: March 11, 2010
• Last updated: July 7, 2011
• Start date: January 2009
• Est. completion date: October 2011

Study information

• Verified date: July 2011
• Source: Ministry of Health, Malaysia
• Contact: Yoke Yeow Yap, MD
• Phone: 0123056912
• Email: yokeyeow[@]yahoo.com
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• FOSCAN
Patients will be randomised to one of two treatment groups. The first group of 26 patients will receive 0.1 mg/kg Foscan® at a drug-light interval of 48 hours (2 days). A single surface illumination light dose of 20 J/cm2 fluence rate of 50 mW at 652 nm will be used. The second reference group of 26 patients will be treated by intracavitary brachytherapy

Locations

Country	Name	City	State
Malaysia	Queen Elizabeth Hospital	Kota Kinabalu	Sabah
Malaysia	Kuala Lumpur Hospital	Kuala Lumpur
Malaysia	Hospital Universiti Sains Malaysia	Kubang Kerian	Kelantan
Malaysia	Universiti Malaysia Sarawak	Kuching	Sarawak
Malaysia	Hospital Pulau Pinang	Penang

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 months	Yes
Secondary	To determine the response rates	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. To evaluate the safety of Foscan-PDT compared with brachytherapy in terms of adverse events and serious adverse events.	12 months	Yes

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