Tolerability of Laser-assisted Cisplatin + 5-fluorouracil- an Exploratory Proof of Concept Study of Topical Combination Chemotherapy for Basal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Occurence of Local Skin Reaction (LSR) Side Effects TOTAL COMPOSITE SCORE
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically-verified, previously untreated superficial or nodular BCCs on the scalp, face, extremities or trunk
- •>18 years of age at baseline
- •Legally competent, able to give verbal and written informed consent
- •Subject in good general health, is willing to participate and can comply with protocol requirements.
- •Fitzpatrick skin phototype I-III
- •Female subjects of childbearing potential1 must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.
排除标准
- •High-risk BCC i. Tumors in the following anatomical locations: midface, orbital, ears ii. Size: >20 mm in facial/scalp areas or > 50 mm in non-facial/non-scalp areas iii. Subtype: morpheaform and micronodular BCC iv. History: Gorlin syndrome or immunosuppression
- •Previous treatment of the BCC lesion
- •Known allergy to cisplatin or Efudix®
- •Other skin diseases present in the treatment area
- •Tattoo in the treatment area which may interfere with or confound evaluation of the study
- •History of keloids which is deemed clinically relevant in the opinion of the investigator
- •Fitzpatrick skin phototype IV-VI
- •Lactating or pregnant women
研究组 & 干预措施
Basal Cell Carcinoma Patients
Patients (>18 years) with histologically-verified superficial or nodular basal cell carcinoma (<20 mm on the face/scalp, <50mm on the trunk/extremities)
干预措施: AFL-assisted cisplatin+5-FU (Drug)
结局指标
主要结局
Change in Occurence of Local Skin Reaction (LSR) Side Effects TOTAL COMPOSITE SCORE
时间窗: Days 1, 3-5, 14, 30 and 3 months post treatment
Non-blinded, clinical evaluation of local erythema, edema, flaking, crusting/scabbing, pustulation, scarring, hypo/hyperpigmentation, infection in treated areas will be performed by a physician using a FDA-approved LSR scale at Days 1, 3-5, 14, 30 and 3 months after AFL exposure. Each parameter was graded on a standardized 5-point severity scale (0-4) representing none, mild, moderate, prominent, and severe. A total composite score reflecting overall LSR severity was then calculated based on the sum of all parameters (minimum score 0- least severe; max score: 24-most severe). lower scores are better.
次要结局
- Tumor Response- Clinical Clearance Determined by Clinical Assessment by Physician(Day 30 and Month 3 post treatment)
- Imaging-based Tumor Response: Complete Tumor Clearance Determined by Physician Performing Imaging(Day 30 and 3 months post treatment)
- Tumor Response- Histological Tumor Clearance Determined by Pathologist(3 months post treatment)
研究者
Merete Haedersdal
Professor, Senior Consultant, PhD, DMSc
Bispebjerg Hospital