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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00473343




Registration number
NCT00473343
Ethics application status
Date submitted
14/05/2007
Date registered
15/05/2007
Date last updated
3/09/2010

Titles & IDs
Public title
Metvix PDT in Patients With "High Risk" Basal Cell Carcinoma
Scientific title
An Open Multicenter, Phase III Study of Photodynamic Therapy With Metvix Cream 160 mg/g in Patients With "High Risk" Basal Cell Carcinoma
Secondary ID [1] 0 0
PC T310/00
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Basal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Photodynamic therapy with Metvix 160 mg/g cream

Treatment: Surgery: Photodynamic therapy with Metvix 160 mg/g cream


Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary end-point will be the histologically confirmed complete response rate within a patient (No BCC cells in the biopsy taken 3 months after the last treatment).
Timepoint [1] 0 0
3 months after last treatment
Secondary outcome [1] 0 0
Safety evaluation during the first 13 weeks or 6 months (if two treatment cycles) after the first Metvix treatment
Timepoint [1] 0 0
13 weeks or 6 months after first freatment
Secondary outcome [2] 0 0
Cosmetic outcome
Timepoint [2] 0 0
12, 24, 36, 48 and 60 months after the first treatment
Secondary outcome [3] 0 0
Recurrence rate
Timepoint [3] 0 0
12, 24, 36, 48 and 60 months after the first treatment

Eligibility
Key inclusion criteria
- Clinical diagnosis of BCC lesions verified by histology (2-3 mm punch biopsy)

- Males or females above 18 years of age.

- Written informed consent. AND

Patients with high risk of surgical complications due to:

- Anticoagulant medication or bleeding disorders

- Cardiac risk factors

- Anaesthetic contraindications

- Poor surgical compliance because of patient refusal, dementia, or inability to perform
wound care.

OR

• Patients with "high-risk BCC lesion(s). A "high-risk" BCC lesion is defined as:

A large BCC lesion with the largest diameter:

- Equal to or greater than 15 mm on extremities, except below the knees, where largest
diameter should be equal to or greater than 10 mm

- Equal to or greater than 20 mm on the trunk

- Equal to or greater than 15 mm in the face, or A lesion in the mid-face region (H-zone
according to Swanson) or on the ear In patients with more then 6 eligible lesions, the
6 lesions to be treated will be randomly chosen.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment of the lesion within 4 weeks.

- A pure morpheaform and/or highly infiltrated lesion assessed clinically and/or by
histology. A mixed nodular/morpheaform lesion which is not highly infiltrated
(clinically) may be included.

- Patient with porphyria.

- Pigmented lesions.

- Known allergy to Metvix® or a similar compound.

- Participation in another clinical study either concurrently or within the last 30 days

- Patient with Gorlin's syndrome.

- Patient with Xeroderma pigmentosum

- Pregnant or breast-feeding (all women of child-bearing potential must document a
negative pregnancy test and use contraception during the treatments and for at least
one month thereafter).

- Conditions associated with a risk of poor protocol compliance.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Department of Dermatology, St. George Hospital - Kogarah
Recruitment hospital [2] 0 0
South East Dermatology, The Belmont Specialist Clinic - Carnia
Recruitment hospital [3] 0 0
Department of Dermatology, Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Dermatology Department, The Queen Elisabeth Hospital - Adelaide
Recruitment hospital [5] 0 0
Clinic B, Repatriation Campus, Austin & Repatriation Medical Centre - Heidelberg
Recruitment hospital [6] 0 0
Fremantle Dermatology - Fremantle
Recruitment hospital [7] 0 0
Dermatology Surgery & Laser Centre, The Perth Surgicentre - Perth
Recruitment postcode(s) [1] 0 0
NSW 2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4152 - Carnia
Recruitment postcode(s) [3] 0 0
SA 5000 - Adelaide
Recruitment postcode(s) [4] 0 0
SA 5011 - Adelaide
Recruitment postcode(s) [5] 0 0
VIC 3081 - Heidelberg
Recruitment postcode(s) [6] 0 0
WA 6106 - Fremantle
Recruitment postcode(s) [7] 0 0
WA 6151 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Galderma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light
activation of a photosensitiser in the presence of oxygen. These cells accumulate more
photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon
illumination.

For skin diseases, there has been an increasing interest in using precursors of the
endogenous photoactive porphyrins. The most commonly used precursors have been
5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix®, contains the
methyl ester of ALA, which penetrates the lesions well and shows high lesion selectivity .

BCC is a highly frequent skin malignancy, and accounts for approximately 75% of all
non-melanoma skin cancers . It is the most common cancer in humans . Several
non-pharmacological treatment modalities are used for BCC, including excision surgery,
curettage and electrodesiccation, cryosurgery and more advanced modalities like radiation
therapy, plastic surgery with reconstruction and Moh's surgery. The treatment used depends on
the type, size, depth and localisation of the BCC lesion. Treatment options for BCC give good
response rates in the majority of patients but are inadequate in a small group of patients
defined as "high-risk" BCC.

In this particular patient group, even a moderate complete response rate with good cosmetic
results may be considered beneficial, since the number of patients who have to receive more
advanced therapy with the possibility of high morbidity and poor cosmetic outcome will be
reduced. Even a partial response is of clinical interest since the remaining tumour will
require less extensive surgery. In the case of treatment failure, Metvix PDT does not
interfere with the use of other treatment modalities.

The variable "complete response" after one or two Metvix treatment cycles will be used as the
basis for the justification of sample size. The following hypothesis will be tested:

H0: Complete response rate of Metvix is less or equal to 65 % versus the alternative
hypothesis HA: Complete response rate of Metvix is greater than 65 %
Trial website
https://clinicaltrials.gov/show/NCT00473343
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carl Vinciullo, MD
Address 0 0
Dermatology Surgery & Laser Centre, Perth
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications