A Multicenter, Phase III, Randomised Study of Photodynamic Therapy With Metvix Cream 160 mg/g in Comparison With Cryotherapy in Patients With Primary Superficial Basal Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 120
- 试验地点
- 14
- 主要终点
- Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT or Cryotherapy Cycle
研究概览
简要总结
The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) methyl aminolevulinate (MAL) cream to cryotherapy, in treatment of participants with primary superficial basal cell carcinoma (BCC).
Secondary objectives was to compare cosmetic outcome and tolerability (adverse events) in these participants, 3 months after treatment. In addition the recurrence rates in the two treatment groups will be compared up to five years after treatment.
详细描述
BCC was a highly frequent skin malignancy, and accounts for approximately 75% of all non-melanoma skin cancers. It is the most common malignant tumour of any organ, mostly affecting head and neck (84%) in fair-skinned people. Several non-pharmacological treatment modalities was used for BCC, including excision surgery, Moh's surgery, radiation, curettage/electrodesiccation and cryotherapy. The treatment used depends on the type, size, depth and localisation of the BCC lesion.
The use of PDT was attractive for the treatment of BCCs because of its efficiency, mild and local side effects and excellent cosmetic outcome. Previous clinical experience was promising and participants with primary BCCs were included in this prospective, randomised, comparative, multicenter study to show that Metvix is non-inferior to alternative treatment with better cosmetic outcome.
The primary end-point is the number of participants in whom 75% or more of the BCC lesions have responded completely at 3 months after PDT with Metvix or 3 months after cryotherapy. Both on-site and independent, blinded response assessments analysed. The analysis based on the results of the independent review board constitutes the primary analysis.
The secondary end-points was the proportion of participants in whom less than 75% of the BCC lesions respond completely, number of lesions across participants that show complete response, evaluation of cosmetic outcome and adverse events 3 months after Metvix PDT or 3 months after cryotherapy. In addition 12, 24, 36, 48 and 60 months recurrence rates was assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •A participant with superficial BCC lesion(s) suitable for entry was defined as a participant with:
- •histologically confirmed diagnosis of primary superficial BCC lesion(s)
- •BCC lesions suitable for cryotherapy
- •males or females above 18 years of age
- •written informed consent. In accordance with Amendment 2 (local amendment), only participant above 19 years of age were to be included in Austria.
排除标准
- •A participant or lesion fulfilling any of the following criteria was ineligible for inclusion:
- •prior treatment of the BCC lesion(s)
- •participant with more than 10 eligible BCC lesions
- •a superficial BCC lesion with the largest diameter exceeding 15 mm on face/scalp, larger than 20 mm on extremities and neck and larger than 30 mm on the trunk
- •a superficial BCC lesion with the largest diameter smaller than 6 mm
- •participant with porphyria
- •participant with Gorlin's syndrome
- •pigmented superficial BCC lesion(s)
- •morpheaform lesion(s)
- •infiltrating lesion(s)
- •participants with a history of arsenic exposure
- •known allergy to Metvix®, a similar PDT compound or excipients of the cream
- •participation in other clinical studies either concurrently or within the last 30 days
- •pregnant or breast-feeding; all women of child-bearing potential had to document a negative pregnancy test and use the pill or intrauterine device during the treatments and for at least one month thereafter
- •conditions associated with a risk of poor protocol compliance.
- •In Amendment 1 the following exclusion criteria were added:
- •xeroderma pigmentosum lesion
- •concurrent use of immunosuppressive medication.
研究组 & 干预措施
Metvix® PDT
Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm*2) up to 13 weeks.
干预措施: Metvix® cream (Drug)
Cryotherapy
Cryotherapy was performed with a hand-held liquid nitrogen spray, using a double freeze-thaw cycle. After an initial icefield formation with a 3 millimeter (mm) rim of clinically healthy tissue, the icefield was to be maintained for a minimum of 20 seconds. This procedure was repeated after a thaw of 2-3 times the freeze time up to 12 weeks.
干预措施: Hand held liquid nitrogen spray cryotherapy (Procedure)
结局指标
主要结局
Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT or Cryotherapy Cycle
时间窗: 3 months after last Metvix PDT or Cryotherapy cycle, up to 6 months
Patient Complete Response (CR) was defined as 100 percentage of the lesions within the participant having negative findings for nodular basal cell carcinoma (BCC) in the histological examination.
次要结局
- Number of Lesion With Complete Response 3 Months After Last Metvix PDT or Cryotherapy Cycle(3 months after last Metvix PDT or Cryotherapy cycle, up to 6 months)
- Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT or Cryotherapy Cycle(3 months after the last metvix PDT or Cryotherapy cycle (Up to 6 months))
- Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT or Cryotherapy Cycle(3 months after the last metvix PDT or Cryotherapy cycle (Up to 6 months))
- Recurrence Rate in Complete Clearance Group(12, 24, 36, 48 and 60 months after last Metvix PDT cycle or Cryotherapy (Up to 5 years))
- Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT or Cryotherapy Cycle(24, 36, 48, and 60 Months After the Last Metvix PDT Cycle (Up to 5 years))