Surgical treatment versus partial debulking prior to cream treatment for skin cancer

Conditions: Histologically proven primary nodular basal cell carcinoma = 4mm and = 20mm in diameter outside the face and hairy scalp.
MedDRA version: 18.0Level: LLTClassification code 10073093Term: Nodular basal cell carcinomaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-003479-52-NL

Lead Sponsor: Maastricht University Medical Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Adults aged 18 years or older
- Primary histologically proven nodular basal cell carcinoma = 4mm and = 20mm in diameter
- Patient is able to apply cream
- Comorbidities may not interfere with study treatment (evaluated by investigator)
- Capable to understand instructions
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 72

Exclusion Criteria

- A nodular BCC located in the face or hairy scalp
- Recurrent (previously treated) nBCC
- Aggressive histopathologcial BCC subtypes
- Life expectancy of less than five years
- Breast-feeding or pregnant women
- Serious comorbidities (evaluated by investigator)
- Use of immunosuppressive medication during the trial period until 3 months after end of treatment or within 30 days before enrolment
- Patients with genetic skin cancer disorders

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare long-term efficacy of curettage prior to IMQ 5% cream (Aldara®) therapy versus standard surgical excision in primary nodular basal cell carcinoma.<br><br>;Secondary Objective: To assess compliance, cosmetic outcomes, patient satisfaction, patient preference and cost-effectiveness.;Primary end point(s): Proportion free of initial nBCC patients at one 1 year after end of treatment (defined as absence of initial treatment failure or any clinical signs of local recurrence).;Timepoint(s) of evaluation of this end point: At 1 year after end of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 5-year cumulative probability of recurrence free survival after end of treatment, compliance, pain, cosmetic appearance, patient satisfaction, patient preference and cost-effectiveness. ;Timepoint(s) of evaluation of this end point: 5-year cumulative probability of recurrence free of initial BCC survival after end of treatment.<br><br>Compliance in imiquimod group at week 6 in patient diary.<br><br>Pain during treatment and two weeks after end of treatment.<br><br>Cosmetic appearance and patient satisfaction after 1 and 5 years after end of treatment.<br><br>Patient preference at start of treatment.<br><br>Cost-effectiveness after 1 and 5 year follow-up.<br><br><br>