Back to resultsFoscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Nasopharyngeal Carcinoma (FOSCAN)
Primary Purpose
Nasopharyngeal Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
FOSCAN
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring recurrent or persistent Nasopharyngeal Carcinoma, treatment of patients with squamous cell carcinoma of the head and neck, Foscan-PDT, Brachytherapy
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
Sites / Locations
- Hospital Universiti Sains Malaysia
- Queen Elizabeth Hospital
- Universiti Malaysia Sarawak
- Kuala Lumpur HospitalRecruiting
- Hospital Pulau Pinang
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nasopharyngeal Carcinoma
Arm Description
A: Experimental B: Active Comparator
Outcomes
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01086488
First Posted
March 11, 2010
Last Updated
July 7, 2011
Sponsor
Ministry of Health, Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT01086488
Brief Title
Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Nasopharyngeal Carcinoma
Acronym
FOSCAN
Official Title
A Phase II, Randomized Controlled Trial of Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Recurrent or Persistent Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Ministry of Health, Malaysia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
recurrent or persistent Nasopharyngeal Carcinoma, treatment of patients with squamous cell carcinoma of the head and neck, Foscan-PDT, Brachytherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nasopharyngeal Carcinoma
Arm Type
Experimental
Arm Description
A: Experimental B: Active Comparator
Intervention Type
Drug
Intervention Name(s)
FOSCAN
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To determine the response rates
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoke Yeow Yap, MD
Phone
0123056912
Email
yokeyeow@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Soo Hwa Teo, PhD
Phone
0126888063
Email
soohwang.teo@carif.com.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoke Yeow Yap, MD
Organizational Affiliation
University Putra Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universiti Sains Malaysia
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baharudin Abdullah, MD
Phone
0139825050
Email
baharudin@kb.usm.my
First Name & Middle Initial & Last Name & Degree
Biswal Mohan, MD
Phone
+6097653370
Facility Name
Queen Elizabeth Hospital
City
Kota Kinabalu
State/Province
Sabah
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chee Lun Lum, MD
Phone
+6088318605
First Name & Middle Initial & Last Name & Degree
Jayendran Dharmaratnam, MD
Phone
+6088438512
Email
navinsurfer@hotmail.com
Facility Name
Universiti Malaysia Sarawak
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93150
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thung Sing Tiong, MD
Phone
+6082422564
First Name & Middle Initial & Last Name & Degree
Vignes Tharumalingam, MD
Phone
01620900002
Facility Name
Kuala Lumpur Hospital
City
Kuala Lumpur
ZIP/Postal Code
53000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoke Yeow Yap, MD
Phone
+60320501001
Email
yokeyeow@yahoo.com
First Name & Middle Initial & Last Name & Degree
Azura Deniel, MD
Phone
+60326925713
Email
azurahkl@yahoo.com
Facility Name
Hospital Pulau Pinang
City
Penang
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kin Choo Pua, MD
Phone
+6044105463
Email
puakinchoo@pph.moh.gov.my
12. IPD Sharing Statement
Links:
URL
http://www.crc.gov.my
Description
Related Info
Learn more about this trial
Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Nasopharyngeal Carcinoma
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