Three non-invasive treatment options of superficial basal cell carcinoma

ISRCTN	ISRCTN79701845
DOI	https://doi.org/10.1186/ISRCTN79701845
Protocol serial number	2007-002776-33
Sponsor	The Netherlands Organisation for Health Research and Development (ZonMw)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Submission date: 01/04/2008
Registration date: 30/04/2008
Last edited: 14/03/2019

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 Nicole Kelleners-Smeets
Scientific

P.Debyelaan 25
Maastricht
6202 AZ
Netherlands

Study information

Primary study design	Interventional
Study design	Randomised single-blind multi-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Three non-invasive treatment options of superficial basal cell carcinoma: photodynamic therapy (PDT) vs imiquimod vs 5-fluorouracil: TTOP-sBCC trial
Study acronym	TTOP-sBCC
Study objectives	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(s)	Medical Ethics Committee of the Maastricht University, 29/10/2007
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Imiquimod, 5-fluorouracil.
Primary outcome measure(s)	1. Clearance rate 3 months after the end of interventions 2. Recurrence rate 1 year after the end of interventions
Key secondary outcome measure(s)	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.
Completion date	01/03/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	Not Specified
Target sample size at registration	600
Total final enrolment	601
Key inclusion criteria	1. Primary histologically proven superficial basal cell carcinoma of the skin 2. Age 18-80 years 3. Both men and women
Key exclusion criteria	1. Genetic skin malignancies 2. Tumour location: peri-ocular, auricular, nasal, hairy scalp 3. Pregnancy 4. Treatment with systemic immunosuppression therapy
Date of first enrolment	01/03/2008
Date of final enrolment	01/03/2011

Locations

Countries of recruitment

Netherlands

Study participating centre

P.Debyelaan 25

Maastricht
6202 AZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	1-year results	01/06/2013		Yes	No
Results article	sub-group analysis results	01/03/2015		Yes	No
Results article	5-year results	01/03/2018	14/03/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/03/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the publication.