A trial comparing Metvix® photodynamic therapy followed by Mohs micrographic surgery against Mohs micrographic surgery alone for the treatment of basal cell carcinoma
| ISRCTN | ISRCTN03814856 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03814856 |
| EudraCT/CTIS number | 2005-004262-16 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/02/2006
- Registration date
- 03/04/2006
- Last edited
- 16/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Habib Kurwa
Scientific
Scientific
Dermatological Surgery and Laser Unit
St John's Institute of Dermatology
St Thomas' Hospital
London
SE1 7EH
United Kingdom
Study information
| Study design | Single centre open randomised controlled pilot study with pre-entry concealment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A trial comparing Metvix® photodynamic therapy followed by Mohs micrographic surgery against Mohs micrographic surgery alone for the treatment of basal cell carcinoma |
| Study objectives | That using topical photodynamic therapy (PDT) prior to Mohs micrographic surgery (as an adjunct) in the treatment of basal cell carcinoma (BCC) will overall, reduce the post-Mohs wound defect size (mm^2) when compared to Mohs micrographic surgery alone |
| Ethics approval(s) | Approved by St Thomas' Hospital Research Ethics Committee on 06/12/2005, reference number: 05/Q0702/219 |
| Health condition(s) or problem(s) studied | Basal cell carcinoma (BCC) |
| Intervention | To assess whether the combination of PDT followed by Mohs micrographic surgery is superior to Mohs micrographic surgery alone in treating basal cell carcinoma in terms of reducing the post-Mohs wound defect and the mean number of stages required to achieve clearance |
| Intervention type | Other |
| Primary outcome measure | 1. To measure and compare the post-Mohs wound defect surface area (mm^2) in the two groups 2. To compare the mean number of stages required to clear the lesion by Mohs' micrographic surgery in the two groups 3. To compare recurrence rates of BCC at 12 months post-operatively. The lesion response will be defined as one complete response (complete clearance) or zero incomplete response (incomplete clearance). |
| Secondary outcome measures | 1. To assess whether there is any reduction in size (surface area, mm^2) of the lesion, clinically with PDT prior to Mohs (in the Metvix® PDT group) including assessment of fluorescence between the first and second sessions of PDT 2. Cosmetic outcome at months 3, 6 and 12 after the Mohs surgery |
| Overall study start date | 06/02/2006 |
| Completion date | 01/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Male or female subjects older than 18 years 2. The above should have a basal cell carcinoma at least 100 mm^2 in surface area and appropriate for treatment with Mohs micrographic surgery 3. Female subject of non-childbearing potential 4. Subject must be willing and capable of cooperating with the study protocol 5. Subject has to be able to read the patient information sheet as well as read and sign the informed consent form prior to any procedure |
| Key exclusion criteria | 1. BCCs with less than 100 mm^2 in surface area 2. Clinically or histologically morphoeic basal cell carcinoma 3. Female of child-bearing potential 4. Subject with a history of porphyria, xeroderma pigmentosa or other photosensitive skin condition 5. Subject with known hypersensitivity to methyl 5-aminolevulinate, a similar compound or excipients of the cream 6. Subject who is at risk in terms of precautions and contraindications in the package insert for Metvix® 7. Subject who has participated in another investigational drug or device research study within 30 days of enrolment 8. Subject with a condition or who is in a situation, which in the investigators opinion may put the subject at significant risk, may confound the study results or may interfere significantly with the subjects participation in the study. This includes individuals unable to understand the implications or procedures of the trial, for example if they cannot adequately understand written or spoken English. |
| Date of first enrolment | 06/02/2006 |
| Date of final enrolment | 01/10/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Dermatological Surgery and Laser Unit
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Guy's and St Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Jackie Pullen
Research and Development
St Thomas' Street
London
SE1 9RT
England
United Kingdom
| Phone | +44 (0)207 1885732 |
|---|---|
| jackie.pullen@gstt.nhs.uk | |
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Government
Guy's and St Thomas' NHS Foundation Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 16/05/2019 | No | No |
Editorial Notes
16/05/2019: Added clinicaltrialsregister.eu link to basic results (scientific).
