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Basal cell carcinoma (BCC) is the most frequent skin cancer. Uncontrolled growth destroys local anatomic structures. There are various treatment alternatives with different recurrence rates and expenses. After surgical excision, the recurrence rate is in between 3 and 4% and the procedure is relatively expensive. Photodynamic therapy as well as imiquimod 5% are expensive therapies with high recurrence rates, that lack histologic evidence of BCC. Cryosurgery and curettage are inexpensive, although the recurrence rates are higher than after surgical excision.
This prospective, randomized trial compares recurrence rates, cosmetic outcome, and surgery-related complications after curettage versus surgical excision in nodular and superficial BCC. About 600 tumors will be included. One half is treated by curettage, the other half by surgical excision. The follow-up period is four years. If the difference between recurrence rates is ≤7% and the cosmetic outcome as well as the surgery-related complications are not worse after curettage, surgical excision must be considered an overtreatment.
Full description
First presentation of a patient with clinical or histopathological diagnosis of BCC
Study patient number, first and surname, date of birth and gender are listed in a distinct file.
Informed consent
Whole body screening for skin cancer
In- or exclusion of the patient. If the patient is excluded, no more data are obtained.
Recording of the following features in an electronic file:
Number of BCCs
Anatomic location
Position
Diameter in mm
In- or exclusion of the tumor
Photographs of the included BCCs
Randomization is performed by the Department of Biostatistics (distance to the Department of Dermatology = 1.7 km) with envelopes containing the assigned study arm. The study physician calls one of four staff members of the Department of Biostatistics and asks for randomization. The envelopes are not opened unless the electronic data file is completed by the study physician.
Disinfection
Local anesthesia
Surgery
Dressing
If histopathology discovers another BCC type than nodular or superficial or even another tumor than BCC, then the tumor is excluded.
Follow-up visit 3 and 6 months (+/- 30 days) after the operation. In BCCs that had to be operated in >1 step, the day of the follow-up visit refers to the initial operation.
In case of clinical suspicion of recurrence of BCC a punch biopsy is taken. If the biopsy confirms recurrence, the endpoint is achieved.
If BCCs must be added to a patient during the recruitment period, follow-up visits always refer to the latest BCC.
If the patient visits our department not within the defined follow-up period, the appointment is not recorded (except confirmation of recurrence).
Patients who provide no feedback receive phone calls.
If a patient or a private practitioner suspect a recurrence of BCC beyond a defined follow-up period, of course, the patient is invited as early as possible to our department, where a biopsy will be taken.
The patient receives a letter containing a list of the BCCs treated within the study. The private practitioner is to be visited with the list after 12, 24, and 36 months (+/- 30 days) referring to the last operation within the recruitment period. The letter contains a questionnaire about scar size and suspicion of recurrence of BCC. The practitioner or the patient return the questionnaire with the answers to our department. If recurrence is suspected we take a biopsy.
When follow-up is closed for an individual patient, the reason is recorded:
Statistic evaluation is based on an intention-to-treat-analysis.
The trial is designed to prove the equivalence of treatment modalities. A statistic test is used for evaluation, including the Kaplan-Meier-method. When all 4 study arms contain 116 BCCs, a 2-group-test on the equivalence of ratios with a 1-sided significance level of 0.05 will have a power of 80% to disprove the null hypothesis. The null hypothesis is that standard and test method are not equivalent (ratio difference delta T - delta S ≥ 0.15). Then the alternative hypothesis is more probable, meaning that the ratios in both groups are equivalent supposed that the expected ratio difference is 0.07 and the ratio within the standard group is 0.03 (according to an expected recurrence rate of 3% in the surgical excision study arm).
Enrollment
Sex
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
Patient Dependent Exclusion Criteria:
Tumor Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
400 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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