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Trial details imported from ClinicalTrials.gov

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

Registration number

NCT00473343

Ethics application status

Date submitted

14/05/2007

Date registered

15/05/2007

Date last updated

5/01/2023

Titles & IDs

Public title

Metvix PDT in Participant 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]

PC T310/00

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Basal Cell Carcinoma

Condition category

Condition code

Cancer

Non melanoma skin cancer

Cancer

Kidney

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Experimental: Metvix® PDT - Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm\*2) up to 13 weeks.

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT Cycle

Timepoint [1]

3 months after last Metvix PDT cycle, up to 6 months

Secondary outcome [1]

Number of Lesion With Complete Response 3 Months After Last Metvix PDT Cycle

Timepoint [1]

3 months after last Metvix PDT cycle, up to 6 months

Secondary outcome [2]

Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT Cycle

Timepoint [2]

3 months after the last metvix PDT cycle, up to 6 months

Secondary outcome [3]

Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT Cycle

Timepoint [3]

3 months after the last metvix PDT cycle, up to 6 months

Secondary outcome [4]

Recurrence Rate in Complete Clearance Group

Timepoint [4]

12, 24, 36, 48 and 60 months after last Metvix PDT cycle, up to 5 years

Secondary outcome [5]

Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle

Timepoint [5]

24, 36, and 60 Months After the Last Metvix PDT Cycle, up to 5 years

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

Participants with high risk of surgical complications due to:

* Anticoagulant medication or bleeding disorders
* Cardiac risk factors
* Anaesthetic contraindications
* Poor surgical compliance because of participant refusal, dementia, or inability to perform wound care.

OR

• Participants 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 participants with more then 6 eligible lesions, the 6 lesions to be treated was randomly chosen.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

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.
* Participant 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
* Participant with Gorlin's syndrome.
* Participant 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

Not applicable

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

1/09/2000

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/06/2006

Sample size

Target

Accrual to date

Final

102

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA,VIC,WA

Recruitment hospital [1]

Department of Dermatology, St. George Hospital - Kogarah

Recruitment hospital [2]

South East Dermatology, The Belmont Specialist Clinic - Carnia

Recruitment hospital [3]

Department of Dermatology, Royal Adelaide Hospital - Adelaide

Recruitment hospital [4]

Dermatology Department, The Queen Elisabeth Hospital - Adelaide

Recruitment hospital [5]

Clinic B, Repatriation Campus, Austin & Repatriation Medical Centre - Heidelberg

Recruitment hospital [6]

Fremantle Dermatology - Fremantle

Recruitment hospital [7]

Dermatology Surgery & Laser Centre, The Perth Surgicentre - Perth

Recruitment postcode(s) [1]

NSW 2217 - Kogarah

Recruitment postcode(s) [2]

4152 - Carnia

Recruitment postcode(s) [3]

SA 5000 - Adelaide

Recruitment postcode(s) [4]

SA 5011 - Adelaide

Recruitment postcode(s) [5]

VIC 3081 - Heidelberg

Recruitment postcode(s) [6]

WA 6106 - Fremantle

Recruitment postcode(s) [7]

WA 6151 - Perth

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Galderma R&D

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 participants but are inadequate in a small group of participants defined as "high-risk" BCC.

In this particular participant group, even a moderate complete response rate with good cosmetic results may be considered beneficial, since the number of participant who have to receive more advanced therapy with the possibility of high morbidity and poor cosmetic outcome was reduced. Even a partial response is of clinical interest since the remaining tumour was 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 was used as the basis for the justification of sample size.

Trial website

https://clinicaltrials.gov/study/NCT00473343

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Carl Vinciullo, MD

Address

Dermatology Surgery & Laser Centre, Perth

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00473343

Trial Review

Registering a new trial?

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