Condition category
Cancer
Date applied
01/04/2008
Date assigned
30/04/2008
Last edited
30/07/2014
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 Nicole Kelleners-Smeets

ORCID ID

Contact details

P.Debyelaan 25
Maastricht
6202 AZ
Netherlands

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 measures

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

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

http://www.zonmw.nl

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23683751
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25066012

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes