Phase II/III study to investigate the efficacy of 5-aminolaevulinic acid (ALA)-based photodynamic therapy in the treatment of Bowen's disease, actinic keratoses and study the effect of dose fractionation for superficial basal cell carcinomas
| ISRCTN | ISRCTN93864182 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93864182 |
| Secondary identifying numbers | N0436118001 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 07/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr F Roberts
Scientific
Scientific
Clinical Oncology
Cookridge Hospital
Hospital Lane
Leeds
LS16 6QB
United Kingdom
Study information
| Study design | Randomised active-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| 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 | Phase II/III study to investigate the efficacy of 5-aminolaevulinic acid (ALA)-based photodynamic therapy in the treatment of Bowen's disease, actinic keratoses and study the effect of dose fractionation for superficial basal cell carcinomas |
| Study objectives | To continue to investigate the efficacy of ALA-based photodynamic therapy in the treatment of Bowen's disease and actinic keratoses. To study the effect of dose fractionation for superficial basal cell carcinomas using a randomised trial. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Bowen's disease |
| Intervention | Controlled trial without randomisation; Randomised controlled trial, Random allocation to: 1 Standard photodynamic therapy for superficial basal cell carcinoma 2 Dose fractionated photodynamic therapy |
| Intervention type | Other |
| Primary outcome measure | Complete remission of skin tumour and future recurrence. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/02/2002 |
| Completion date | 01/02/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Recruited from clinical oncology consultants to whom patients are referred at a district general hospital. Also direct from consultant dermatologists/plastic surgeons in Leeds and Airedale. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/02/2002 |
| Date of final enrolment | 01/02/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cookridge Hospital
Leeds
LS16 6QB
United Kingdom
LS16 6QB
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Leeds Teaching Hospitals NHS 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 |
