Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2007-002776-33
Study information
Scientific title
Three non-invasive treatment options of superficial basal cell carcinoma: photodynamic therapy (PDT) vs imiquimod vs 5-fluorouracil: TTOP-sBCC trial
Acronym
TTOP-sBCC
Study hypothesis
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.
Ethics approval
Medical Ethics Committee of the Maastricht University, 29/10/2007
Study design
Randomised single-blind multi-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Superficial basal cell carcinoma
Intervention
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)
Intervention type
Drug
Phase
Not Applicable
Drug names
Imiquimod, 5-fluorouracil.
Primary outcome measure
1. Clearance rate 3 months after the end of interventions
2. Recurrence rate 1 year after the end of interventions
Secondary outcome measures
1. Cost effectiveness
2. Patient preference, assessed by a questionnaire 1.5 years 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 scar evaluation. Plast Reconstr Surg. 2004 Jun; 113(7): 1960-5) and a 5-point scale.
Overall trial start date
01/03/2008
Overall trial end date
01/03/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Primary histologically proven superficial basal cell carcinoma of the skin
2. Age 18-80 years
3. Both men and women
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
600 patients
Participant exclusion criteria
1. Genetic skin malignancies
2. Tumour location: peri-ocular, auricular, nasal, hairy scalp
3. Pregnancy
4. Treatment with systemic immunosuppression therapy
Recruitment start date
01/03/2008
Recruitment end date
01/03/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
P.Debyelaan 25
Maastricht
6202 AZ
Netherlands
Sponsor information
Organisation
The Netherlands Organisation for Health Research and Development (ZonMw)
Sponsor details
Postbus 93 245
Den Haag
2509 AE
Netherlands
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23683751
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25066012
Publication citations
-
Results
Arits AH, Mosterd K, Essers BA, Spoorenberg E, Sommer A, De Rooij MJ, van Pelt HP, Quaedvlieg PJ, Krekels GA, van Neer PA, Rijzewijk JJ, van Geest AJ, Steijlen PM, Nelemans PJ, Kelleners-Smeets NW, Photodynamic therapy versus topical imiquimod versus topical fluorouracil for treatment of superficial basal-cell carcinoma: a single blind, non-inferiority, randomised controlled trial., Lancet Oncol., 2013, 14, 7, 647-654, doi: 10.1016/S1470-2045(13)70143-8.
-
Results
Roozeboom MH, Nelemans PJ, Mosterd K, Steijlen PM, Arits AH, Kelleners-Smeets NW, Photodynamic therapy versus topical imiquimod for treatment of superficial basal cell carcinoma: a subgroup analysis within a non-inferiority randomised controlled trial., Br. J. Dermatol., 2014, doi: 10.1111/bjd.13299.