Clinical trial NCT03541252
Conditions: Carcinoma, Basal Cell
Sponsor: Merete Haedersdal
Start date: 2018-03-09; Completion date: 2019-09-02
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A prospective clinical, uncontrolled, open-label, explorative phase IIa trial on patients with histologically- confirmed superficial and nodular basal cell carcinoma (BCC) . The study assesses tolerability and tumor clearance after laser-assisted topical delivery of two synergistic chemotherapeutic agents, cisplatin and 5-fluorouracil (5-FU) in BCC patients.

Detailed description:
Patients will receive ablative fractional laser (AFL)-assisted cisplatin+5-fluorouracil (5-FU) as a treatment for their cutaneous basal cell carcinoma (BCC). In brief, treatment areas consisting of tumors and a 5 mm margin will undergo AFL exposure (CO2 laser) followed by 60 min topical application of a marketed and commercially available IV cisplatin solution (0.1%) at a dose of 0.25 ml per cm2. After removal of cisplatin, a commercially distributed 5-FU cream (5% Efudix®) will be applied to the treatment area at a dose of 0.125 ml per cm2 and left under occlusion. After skin evaluations on Day 1 and 5 after treatment, the same 5-FU dose will be applied, again left under occlusion. In total, 5-FU will remain on the skin for 7 days after AFL treatment whereafter it will be washed off.

An additional repeat AFL-cisplatin+5-FU treatment on Day 30 will be offered if tumors persist, based on clinical evaluation and imaging on Day 30.

Outcome measures and methods/techniques are summarized below.

Primary outcome:

To investigate tolerability of topical AFL-assisted cisplatin+5-FU therapy for BCC by evaluating:

I. Severity and duration of clinical local skin reactions including erythema, edema, scabbing, flaking and pustulation assessed by a physician using an established 0-4 point scale (none, mild, moderate, severe) from 0-30 days post-treatment.

II. Occurrence of side effects (prolonged erythema/edema, hyper/hypopigmentation, scarring and infection) up to 3 months post-treatment.

Secondary outcome:

1\) To monitor BCC tumor size and clearance based on clinical assessments and dermoscopy, supported by non-invasive imaging techniques including dynamic optical coherence tomography (D-OCT), reflectance confocal microscopy (RCM), high intensity focused ultrasound (HIFU) and histological analysis up to 3 months post-treatment.

Arms: arm 1: Patients (\>18 years) with histologically-verified superficial or nodular basal cell carcinoma (\<20 mm on the face/scalp, \<50mm on the trunk/extremities)
Interventions: intervention 1: AFL-assisted cisplatin+5-FU
Intervention descriptions: intervention 1: Patients will receive AFL-assisted cisplatin+5-FU as a treatment for their BCC. In brief, treatment areas consisting of tumors and a 5 mm margin will undergo CO2 laser exposure followed by 60 min topical application of a marketed and commercially available IV cisplatin solution (0.1%) After removal of cisplatin, a commercially distributed 5-FU cream (5%) will be applied to the treatment area at a dose of 0.125 ml per cm2 and left under occlusion. After skin evaluations on Day 1 and 5 after treatment, the same 5-FU dose will be applied, again left under occlusion. In total, 5-FU will remain on the skin for 7 days after AFL treatment whereafter it will be washed off. An additional repeat AFL-cisplatin+5-FU treatment on Day 30 will be offered if tumors persist, based on clinical evaluation and imaging on Day 30.

Protocol documents:
Prot_SAP_000.pdf: