An Open Multicenter, Phase III Study of Photodynamic Therapy With Metvix® Cream 160 mg/g in Patients With "High Risk" 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
- 102
- 试验地点
- 7
- 主要终点
- Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT Cycle
研究概览
简要总结
Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulate more photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon illumination.
For skin diseases, there has been an increasing interest in using precursors of the endogenous photoactive porphyrins. The most commonly used precursors have been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix®, contains the methyl ester of ALA, which penetrates the lesions well and shows high lesion selectivity .
BCC is a highly frequent skin malignancy, and accounts for approximately 75% of all non-melanoma skin cancers. It is the most common cancer in humans. Several non-pharmacological treatment modalities are used for BCC, including excision surgery, curettage and electrodesiccation, cryosurgery and more advanced modalities like radiation therapy, plastic surgery with reconstruction and Moh's surgery. The treatment used depends on the type, size, depth and localisation of the BCC lesion. Treatment options for BCC give good response rates in the majority of participants but are inadequate in a small group of participants defined as "high-risk" BCC.
In this particular participant group, even a moderate complete response rate with good cosmetic results may be considered beneficial, since the number of participant who have to receive more advanced therapy with the possibility of high morbidity and poor cosmetic outcome was reduced. Even a partial response is of clinical interest since the remaining tumour was require less extensive surgery. In the case of treatment failure, Metvix PDT does not interfere with the use of other treatment modalities.
The variable "complete response" after one or two Metvix treatment cycles was used as the basis for the justification of sample size.
详细描述
Prospective, open, multicenter study. The high risk BCC lesions were treated with Metvix cream. A biopsy confirming the diagnosis of each BCC lesion should have been taken within 6 months prior to treatment. The participants was receive one or two treatment cycles each consisting of two Metvix PDT treatments 7 days apart (Lesions that did not respond completely after three months received a second PDT treatment cycle).
The primary end-point was the histologically confirmed complete response rate within a participant (No BCC cells in the biopsy taken 3 months after the last treatment).
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
- •Clinical diagnosis of BCC lesions verified by histology (2-3 mm punch biopsy)
- •Males or females above 18 years of age.
- •Written informed consent. AND
- •Participants with high risk of surgical complications due to:
- •Anticoagulant medication or bleeding disorders
- •Cardiac risk factors
- •Anaesthetic contraindications
- •Poor surgical compliance because of participant refusal, dementia, or inability to perform wound care.
- •Participants with "high-risk BCC lesion(s). A "high-risk" BCC lesion is defined as:
- •A large BCC lesion with the largest diameter:
- •Equal to or greater than 15 mm on extremities, except below the knees, where largest diameter should be equal to or greater than 10 mm
- •Equal to or greater than 20 mm on the trunk
- •Equal to or greater than 15 mm in the face, or A lesion in the mid-face region (H-zone according to Swanson) or on the ear In participants with more then 6 eligible lesions, the 6 lesions to be treated was randomly chosen.
排除标准
- •Prior treatment of the lesion within 4 weeks.
- •A pure morpheaform and/or highly infiltrated lesion assessed clinically and/or by histology. A mixed nodular/morpheaform lesion which is not highly infiltrated (clinically) may be included.
- •Participant with porphyria.
- •Pigmented lesions.
- •Known allergy to Metvix® or a similar compound.
- •Participation in another clinical study either concurrently or within the last 30 days
- •Participant with Gorlin's syndrome.
- •Participant with Xeroderma pigmentosum
- •Pregnant or breast-feeding (all women of child-bearing potential must document a negative pregnancy test and use contraception during the treatments and for at least one month thereafter).
- •Conditions associated with a risk of poor protocol compliance.
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)
结局指标
主要结局
Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT Cycle
时间窗: 3 months after last Metvix PDT 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
- Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT Cycle(3 months after the last metvix PDT cycle, up to 6 months)
- Recurrence Rate in Complete Clearance Group(12, 24, 36, 48 and 60 months after last Metvix PDT cycle, up to 5 years)
- Number of Lesion With Complete Response 3 Months After Last Metvix PDT Cycle(3 months after last Metvix PDT cycle, up to 6 months)
- Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT Cycle(3 months after the last metvix PDT cycle, up to 6 months)
- Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle(24, 36, and 60 Months After the Last Metvix PDT Cycle, up to 5 years)