Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
07/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr F Roberts

ORCID ID

Contact details

Clinical Oncology
Cookridge Hospital
Hospital Lane
Leeds
LS16 6QB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436118001

Study information

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised active-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase II/III

Drug names

Primary outcome measures

Complete remission of skin tumour and future recurrence.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2002

Overall trial end date

01/02/2004

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/02/2002

Recruitment end date

01/02/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cookridge Hospital
Leeds
LS16 6QB
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes