Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12615001061527
Ethics application status
Approved
Date submitted
8/09/2015
Date registered
12/10/2015
Date last updated
19/11/2019
Date data sharing statement initially provided
19/11/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
A Pilot Randomised Controlled Pilot Study to Assess the Efficacy of Photodynamic Therapy vs. Radiotherapy for Superficial Skin Cancer.
Query!
Scientific title
A Randomised Controlled Pilot Study to Assess the Efficacy of Photodynamic Therapy vs. Radiotherapy for the Control of Basal Cell Carcinoma and Bowen's Disease.
Query!
Secondary ID [1]
287240
0
Nil known
Query!
Universal Trial Number (UTN)
Nil
Query!
Trial acronym
PDRT
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Basal Cell Carcinoma
295847
0
Query!
Bowen's Disease
295849
0
Query!
Condition category
Condition code
Cancer
296102
296102
0
0
Query!
Non melanoma skin cancer
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
The participant will be randomised 1:1 to Photodynamic Therapy or Radiotherapy.
A Dermatologist will be responsible for the Photodynamic Therapy as part of their normal practice. Photodynamic Therapy involves the application of a topical photosensitising agent, Methyl Aminolevulinate Hydrochloride (MAL) cream, to the area to be treated. 160mg/g is applied with a 10mm margin at least 1mm thick. Occlusive and opaque dressing is then applied for 3 hours.
The application of MAL makes Basal Cell Carcinoma/Bowen's Disease cells sensitive to a certain type of light. Illumination leads to the release of reactive oxygen species within the target tissue. Local anaesthesia with 1% lignocaine by injection (subcutaneous or dermal) will be offered prior to illumination.
The area is illuminated with noncoherent red light at a wavelength of 630 nm for a total dose of 37 joules/cm2. The light source is placed 5-8cm away, and parallel to the skin surface. The duration of illumination is approximately 9 minutes. When the area is exposed to the light source, neoplastic cells are destroyed by either necrosis or apoptosis. Illumination is given as two 'fractions' approximately 1-4 weeks apart. This treatment is available on Medicare at St Vincent's Hospital, Sydney.
Query!
Intervention code [1]
292528
0
Treatment: Devices
Query!
Intervention code [2]
293025
0
Treatment: Drugs
Query!
Comparator / control treatment
The comparator, Radiotherapy, uses high-energy radiation to kill Basal Cell Carcinoma/Bowen's Disease cells. The radiation is focused from outside the body onto the tumour.
The following modalities are allowed: Superficial X-Ray Therapy, Electrons, Brachytherapy Moulds, Tangential Volumetric Modulated Arc Therapy, No Grenz. For Superficial X-Ray Therapy, a margin of at least 5mm is added to the lesions. For other therapies, a margin of at least 10mm is added to the lesion. Treatment depth is 5mm.
EVIQ guidelines will be followed for the dose. Options include:
- 60 Gy in 30 fractions, 2 Gy per fraction
- 55 Gy in 30 fractions, 2.2 Gy per fraction
- 50 Gy in 20 fractions, 2.5 Gy per fraction
- Field 2-5cm max: 45 Gy in 15 fractions, 3 Gy per fraction
- Or 40 Gy in 10 fractions, 4 Gy per fraction (3# per week)
Field 2cm max: 30-35 Gy in 5 fractions, 6-7 Gy per fraction (2-3# per week)
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
295772
0
To assess the efficacy of Photodynamic Therapy vs. Radiotherapy in terms of clinical clearance rate, as determined by a dermatologist, at 1 year post-treatment.
Query!
Assessment method [1]
295772
0
Query!
Timepoint [1]
295772
0
1 year post final treatment dose.
Query!
Secondary outcome [1]
316501
0
To assess the recurrence rate at 3 months and 2 years post-treatment , as determined by a dermatologist (any clinical recurrence is to be histologically confirmed).
Query!
Assessment method [1]
316501
0
Query!
Timepoint [1]
316501
0
3 months and 2 year post-treatment dose.
Query!
Secondary outcome [2]
317976
0
To assess quality of life at 3 months, 1 year, and 2 years post-treatment via the Patient and Observer Scar Assessment Scale.
Query!
Assessment method [2]
317976
0
Query!
Timepoint [2]
317976
0
3 months, 1 and 2 years post final treatment dose.
Query!
Secondary outcome [3]
317977
0
To assess cosmetic outcome via the blinded assessment of photographs at 3 months, 1 year, and 2 years post-treatment. The presence and degree of the following will be considered: scarring, atrophy, dyspigmentation, telangiectasia, contracture and distortion.
Query!
Assessment method [3]
317977
0
Query!
Timepoint [3]
317977
0
3 months, 1 and 2 years post final treatment dose.
Query!
Secondary outcome [4]
317983
0
To analyse the cost of treatment provided by review of hospital records.
Query!
Assessment method [4]
317983
0
Query!
Timepoint [4]
317983
0
2 years.
Query!
Eligibility
Key inclusion criteria
1 Biopsy-proven superficial BCC or Bowen’s disease.
2 De novo lesions; i.e. lesions previously untreated.
3 Lesion able to be treated by PDT or RT.
4 Lesion originally at least 10mm in maximum dimension(this is to facilitate a single 3mm punch biopsy needed for diagnosis and for an optional translation study based on immunohistochemical staining of the diagnostic biopsy).
5 18 years or older.
6 Patient is not suitable for surgery either because surgery is too great a burden, the patient is not capable of having surgery (usually due to comorbidity) or has refused surgery.
7 Immunosuppressed patients to be included (HIV, Transplant, Auto immune being actively treated (i.e. with chemotherapy (CTX) or steroid dose over 7mg prednisolone equivalent daily) with stratification.
8 Life expectancy of at least 2 years.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1 Lesions unsuitable for PDT or radiotherapy: More infiltrative skin cancers (including nodular, micronodular, infiltrative, morphoeic BCC or infiltrating SCC); Perineural invasion; Subungual lesions; Perioccular lesions unable to be treated by PDT or RT; Larger than PDT field (8x18cm); Pigmented BCC; Genital and perianal lesions
2 Aged under 18 years
3 Unable to attend treatment for practical reasons
4 Porphyria, SLE
5 Pregnancy, lactation
6 Unable to have RT – e.g. Gorlins, XP.
7 Photosensitive disorder to visible light spectrum
8 Hypersensitivity to the Metvix cream
9 Previous treatment to index lesion
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Treatment will be randomly allocated 1:1 to Photodynamic Therapy or Radiotherapy. Allocation will be concealed by contacting the holder of the allocation schedule who is based at the central administration site.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Withdrawn
Query!
Reason for early stopping/withdrawal
Other reasons/comments
Query!
Other reasons
Superseded by another trial
Query!
Date of first participant enrolment
Anticipated
1/10/2018
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
100
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
4143
0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Query!
Recruitment postcode(s) [1]
10075
0
2010 - Darlinghurst
Query!
Funding & Sponsors
Funding source category [1]
291807
0
Hospital
Query!
Name [1]
291807
0
St Vincent's Hospital, Sydney
Query!
Address [1]
291807
0
390 Victoria Street
Darlinghurst
NSW 2010
Query!
Country [1]
291807
0
Australia
Query!
Primary sponsor type
Hospital
Query!
Name
St Vincent's Hospital, Sydney
Query!
Address
390 Victoria Street
Darlinghurst
NSW 2010
Query!
Country
Australia
Query!
Secondary sponsor category [1]
290469
0
None
Query!
Name [1]
290469
0
Query!
Address [1]
290469
0
Query!
Country [1]
290469
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
293324
0
St Vincent's Hospital, Sydney
Query!
Ethics committee address [1]
293324
0
390 Victoria Street
Darlinghurst
NSW 2010
Query!
Ethics committee country [1]
293324
0
Australia
Query!
Date submitted for ethics approval [1]
293324
0
Query!
Approval date [1]
293324
0
16/06/2015
Query!
Ethics approval number [1]
293324
0
Query!
Summary
Brief summary
This study's purpose is to compare photodynamic therapy with radiation therapy (RT) for superficial skin cancer.
Who is it for?
You may be eligible to join this study if you have received a biopsy-proven diagnosis of superficial basal cell carcinoma or Bowen’s disease, for which you have received no previous treatment.
Study Details:
Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive photodynamic therapy, which involves the application of a topical agent to the area to be treated, and then application of a certain type of light. A red light will be placed 5-8cm away from your skin surface for approximately 9 minutes. You will receive two sets of treatment 1-4 weeks apart. Participants assigned to the other group will receive radiation therapy, which involves highly-focused radiation from outside the body onto the lesion site to destroy cancerous cells.
Participants will be asked to undergo clinical assessments (including photos to assess cosmetic outcomes) and complete questionnaires before treatment and 3 months, 1 year and 2 years post-treatment.
It is hoped that this research will provide insight in the efficacy and cosmetic outcomes of two different types of non-surgical intervention of skin cancer.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
59390
0
Prof Gerald Fogarty
Query!
Address
59390
0
Department of Radiation Oncology
St Vincent's Hospital
390 Victoria Street
Darlinghurst
NSW 2010
Query!
Country
59390
0
Australia
Query!
Phone
59390
0
+61 2 8382 6798
Query!
Fax
59390
0
Query!
Email
59390
0
gerald.fogarty@cancer.com.au
Query!
Contact person for public queries
Name
59391
0
Prof Gerald Fogarty
Query!
Address
59391
0
Department of Radiation Oncology
St Vincent's Hospital
390 Victoria Street
Darlinghurst
NSW 2010
Query!
Country
59391
0
Australia
Query!
Phone
59391
0
+61 2 8382 6798
Query!
Fax
59391
0
Query!
Email
59391
0
gerald.fogarty@cancer.com.au
Query!
Contact person for scientific queries
Name
59392
0
Prof Gerald Fogarty
Query!
Address
59392
0
Department of Radiation Oncology
St Vincent's Hospital
390 Victoria Street
Darlinghurst
NSW 2010
Query!
Country
59392
0
Australia
Query!
Phone
59392
0
+61 2 8382 6798
Query!
Fax
59392
0
Query!
Email
59392
0
gerald.fogarty@cancer.com.au
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Not apart of ethics submission
Query!
What supporting documents are/will be available?
No other documents available
Query!
Summary results
No Results
Download to PDF