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ISRCTN
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ISRCTN79701845
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ClinicalTrials.gov identifier
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Public title
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Three non-invasive treatment options of superficial basal cell carcinoma
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Scientific title
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Three non-invasive treatment options of superficial basal cell carcinoma: Photodynamic therapy (PDT) vs imiquimod vs 5-fluorouracil: TTOP-sBCC trial
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Acronym
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TTOP-sBCC
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Serial number at source
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2007-002776-33
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Study hypothesis
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There is no significant difference in recurrence rate and cosmetic outcome between the three treatment options. There will be a significant difference in cost effectiveness, PDT is expected to be much more expensive than the other two treatment options.
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Ethics approval
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Medical Ethics Committee of the Maastricht University. Date of approval: 29/10/2007
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Study design
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Randomised, single-blind, multi-centre trial.
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Countries of recruitment
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The Netherlands
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Disease/condition/study domain
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Superficial basal cell carcinoma
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Participants - inclusion criteria
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1. Primary histologically proven superficial basal cell carcinoma of the skin
2. Patients age: 18-80 years
3. Both men and women
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Participants - exclusion criteria
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1. Genetic skin malignancies
2. Tumour location: peri-ocular, auricular, nasal, hairy scalp
3. Pregnancy
4. Treatment with systemic immunosuppression therapy
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Anticipated start date
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01/03/2008
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Anticipated end date
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01/03/2011
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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600 patients
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Interventions
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Arm 1: Photodynamic therapy with Metvix®, 2 times 37 J/cm^2 with one week between the two sessions. Lamp used: Omnilux PDT™, Waldmann PDT™ or Aktilite PDT™ (Galderma).
Arm 2: Imiquimod (Aldara®): 5/7 days, once a day for 6 weeks
Arm 3: 5-fluorouracil (Efudix®): 7/7 days, two times a day for 4 weeks
Follow up: 3 months-12 months (-2 years-3 years-4 years-5 years)
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Primary outcome measure(s)
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1. Clearance rate 3 months after the end of interventions
2. Recurrence rate 1 year after the end of interventions
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Secondary outcome measure(s)
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1. Cost effectiveness
2. Patient preference, assessed by a questionnaire 1.5 year after the start of the study
3. Compliance, assessed by a questionnaire based on items of the Brief Medication Questionnaire (ref: Svarstad BL et al. The Brief Medication Questionnaire: a tool for screening patient adherence and barriers to adherence. Patient educ couns. 1999 Jun; 37(2): 113-24).
4. Side effects (pain), assessed using a questionnaire during treatment
5. Cosmetic outcome at 3 months and 1 year, assessed by both patient and one blinded medical doctor using the Patient and Observer scale (ref: Draaijers LJ et al. The patient and observer scare assessment scale: A reliable and feasible tool for scare evaluation. Plast Reconstr Surg. 2004 Jun; 113(7): 1960-5) and a 5 point scale.
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Sources of funding
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The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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Trial website
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Publications
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Contact name
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Dr
Nicole
Kelleners-Smeets
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Address
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P.Debyelaan 25
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City/town
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Maastricht
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Zip/Postcode
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6202 AZ
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Country
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Netherlands
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Sponsor
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The Netherlands Organisation for Health Research and Development (ZonMw)
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Address
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Postbus 93 245
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City/town
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Den Haag
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Zip/Postcode
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2509 AE
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Country
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Netherlands
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Sponsor website:
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http://www.zonmw.nl
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Date applied
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01/04/2008
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Last edited
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30/04/2008
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Date ISRCTN assigned
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30/04/2008
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