Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Nasopharyngeal Carcinoma (FOSCAN)
- 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.
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II, Randomized Controlled Trial of Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Recurrent or Persistent Nasopharyngeal Carcinoma|
- 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. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- To determine the response rates [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||October 2011|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Nasopharyngeal Carcinoma
A: Experimental B: Active Comparator
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
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.
|Contact: Yoke Yeow Yap, MDfirstname.lastname@example.org|
|Contact: Soo Hwa Teo, PhDemail@example.com|
|Hospital Universiti Sains Malaysia||Not yet recruiting|
|Kubang Kerian, Kelantan, Malaysia, 16150|
|Contact: Baharudin Abdullah, MD 0139825050 firstname.lastname@example.org|
|Contact: Biswal Mohan, MD +6097653370|
|Queen Elizabeth Hospital||Not yet recruiting|
|Kota Kinabalu, Sabah, Malaysia|
|Contact: Chee Lun Lum, MD +6088318605|
|Contact: Jayendran Dharmaratnam, MD +6088438512 email@example.com|
|Universiti Malaysia Sarawak||Not yet recruiting|
|Kuching, Sarawak, Malaysia, 93150|
|Contact: Thung Sing Tiong, MD +6082422564|
|Contact: Vignes Tharumalingam, MD 01620900002|
|Kuala Lumpur Hospital||Recruiting|
|Kuala Lumpur, Malaysia, 53000|
|Contact: Yoke Yeow Yap, MD +60320501001 firstname.lastname@example.org|
|Contact: Azura Deniel, MD +60326925713 email@example.com|
|Hospital Pulau Pinang||Not yet recruiting|
|Contact: Kin Choo Pua, MD +6044105463 firstname.lastname@example.org|
|Principal Investigator:||Yoke Yeow Yap, MD||University Putra Malaysia|