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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.
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.
Secondary ID [1] 287240 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
PDRT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Basal Cell Carcinoma
 295847 0
Bowen's Disease 295849 0
Condition category
Condition code
Cancer 296102 296102 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 292528 0
Treatment: Devices
Intervention code [2] 293025 0
Treatment: Drugs
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)
Control group
Active

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.
Timepoint [1] 295772 0
1 year post final treatment dose.
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).
Timepoint [1] 316501 0
3 months and 2 year post-treatment dose.
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.
Timepoint [2] 317976 0
3 months, 1 and 2 years post final treatment dose.
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.
Timepoint [3] 317977 0
3 months, 1 and 2 years post final treatment dose.
Secondary outcome [4] 317983 0
To analyse the cost of treatment provided by review of hospital records.
Timepoint [4] 317983 0
2 years.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Superseded by another trial
Date of first participant enrolment
Anticipated
1/10/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4143 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 10075 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 291807 0
Hospital
Name [1] 291807 0
St Vincent's Hospital, Sydney
Country [1] 291807 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
390 Victoria Street
Darlinghurst
NSW 2010
Country
Australia
Secondary sponsor category [1] 290469 0
None
Name [1] 290469 0
Address [1] 290469 0
Country [1] 290469 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293324 0
St Vincent's Hospital, Sydney
Ethics committee address [1] 293324 0
390 Victoria Street
Darlinghurst
NSW 2010
Ethics committee country [1] 293324 0
Australia
Date submitted for ethics approval [1] 293324 0
Approval date [1] 293324 0
16/06/2015
Ethics approval number [1] 293324 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59390 0
Prof Gerald Fogarty
Address 59390 0
Department of Radiation Oncology
St Vincent's Hospital
390 Victoria Street
Darlinghurst
NSW 2010
Country 59390 0
Australia
Phone 59390 0
+61 2 8382 6798
Fax 59390 0
Email 59390 0
[email protected]
Contact person for public queries
Name 59391 0
Gerald Fogarty
Address 59391 0
Department of Radiation Oncology
St Vincent's Hospital
390 Victoria Street
Darlinghurst
NSW 2010
Country 59391 0
Australia
Phone 59391 0
+61 2 8382 6798
Fax 59391 0
Email 59391 0
[email protected]
Contact person for scientific queries
Name 59392 0
Gerald Fogarty
Address 59392 0
Department of Radiation Oncology
St Vincent's Hospital
390 Victoria Street
Darlinghurst
NSW 2010
Country 59392 0
Australia
Phone 59392 0
+61 2 8382 6798
Fax 59392 0
Email 59392 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not apart of ethics submission


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.