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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Ministry of Health, Malaysia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ministry of Health, Malaysia
ClinicalTrials.gov Identifier:
NCT01086488
First received: March 11, 2010
Last updated: July 7, 2011
Last verified: July 2011
  Purpose

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.

Condition Intervention Phase
Nasopharyngeal Carcinoma
Drug: FOSCAN
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Malaysia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 66
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)
Arms Assigned Interventions
Experimental: Nasopharyngeal Carcinoma
A: Experimental B: Active Comparator
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086488

Contacts
Contact: Yoke Yeow Yap, MD 0123056912 yokeyeow@yahoo.com
Contact: Soo Hwa Teo, PhD 0126888063 soohwang.teo@carif.com.my

Locations
Malaysia
Hospital Universiti Sains Malaysia Not yet recruiting
Kubang Kerian, Kelantan, Malaysia, 16150
Contact: Baharudin Abdullah, MD    0139825050    baharudin@kb.usm.my   
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    navinsurfer@hotmail.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    yokeyeow@yahoo.com   
Contact: Azura Deniel, MD    +60326925713    azurahkl@yahoo.com   
Hospital Pulau Pinang Not yet recruiting
Penang, Malaysia
Contact: Kin Choo Pua, MD    +6044105463    puakinchoo@pph.moh.gov.my   
Sponsors and Collaborators
Ministry of Health, Malaysia
Investigators
Principal Investigator: Yoke Yeow Yap, MD University Putra Malaysia
  More Information

Additional Information:
No publications provided

Responsible Party: Yoke-Yeow Yap, MD, Name/Official Title: Dr. Yap Yoke Yeow
ClinicalTrials.gov Identifier: NCT01086488     History of Changes
Other Study ID Numbers: CT 08-03, major research grant
Study First Received: March 11, 2010
Last Updated: July 7, 2011
Health Authority: Malaysia: Ministry of Health

Keywords provided by Ministry of Health, Malaysia:
recurrent or persistent Nasopharyngeal Carcinoma
treatment of patients with squamous cell carcinoma of the head and neck
Foscan-PDT
Brachytherapy

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Temoporfin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Photosensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on August 21, 2014