Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Nasopharyngeal Carcinoma
FOSCAN
A Phase II, Randomized Controlled Trial of Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Recurrent or Persistent Nasopharyngeal Carcinoma
2 other identifiers
interventional
66
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2009
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 11, 2010
CompletedFirst Posted
Study publicly available on registry
March 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedJuly 8, 2011
July 1, 2011
2.7 years
March 11, 2010
July 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
To determine the response rates
12 months
Study Arms (1)
Nasopharyngeal Carcinoma
EXPERIMENTALA: Experimental B: Active Comparator
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150, Malaysia
Queen Elizabeth Hospital
Kota Kinabalu, Sabah, Malaysia
Universiti Malaysia Sarawak
Kuching, Sarawak, 93150, Malaysia
Hospital Pulau Pinang
George Town, Malaysia
Kuala Lumpur Hospital
Kuala Lumpur, 53000, Malaysia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yoke Yeow Yap, MD
University Putra Malaysia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
March 11, 2010
First Posted
March 15, 2010
Study Start
January 1, 2009
Primary Completion
September 1, 2011
Study Completion
October 1, 2011
Last Updated
July 8, 2011
Record last verified: 2011-07