Three non-invasive treatment options of superficial basal cell carcinoma
| ISRCTN | ISRCTN79701845 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79701845 |
| Secondary identifying numbers | 2007-002776-33 |
- 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
Scientific
P.Debyelaan 25
Maastricht
6202 AZ
Netherlands
Study information
| Study design | Randomised single-blind multi-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| 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 | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/03/2008 |
| 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 number of participants | 600 patients |
| 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
6202 AZ
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw)
Research organisation
Research organisation
Postbus 93 245
Den Haag
2509 AE
Netherlands
| Website | http://www.zonmw.nl |
|---|---|
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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 |
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 |
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.
