Intralesional Methotrexate Versus Intramuscular Methotrexate in the Treatment of Non-melanoma Skin Cancers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in size and number of tumors
研究概览
简要总结
to compare the effectiveness and safety of intralesional vs. systemic MTX in NMSC management
详细描述
Intralesional methotrexate (MTX) could to be promising conservative alternative for non-melanoma skin cancer (NMSC). Systemic MTX was attempted as adjuvant for locally-advanced NMSC.
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
- Double (Participant, Care Provider)
盲法说明
Double-blinded
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of both sexes with histologically-confirmed primary or recurrent non- metastatic NMSCs of different types (BCC,SCC, and/or KA), sites, number, sizes and duration were included in the study.
排除标准
- •Hypersensitivity reactions to methotrexate, liver or kidney disease, immunosuppressive conditions, HIV, HBV, and HCV infection, hematological abnormalities and metastasis. Pregnant or lactating women, females in their child-bearing period not using or refusing contraceptive methods, and those who had any other form of NMSC management in the month preceding enrollment.
研究组 & 干预措施
Intralesional methotrexate
Group A 30 patients received intralesional injection of MTX with an insulin syringe into the tumor at a dose ranging between 12.5 mg to 25 mg according to the tumor size every week until complete improvement or for a maximum of 8 sessions.
干预措施: Methotrexate (Drug)
Intramuscular methotrexate
Group B 30 patients received systemic MTX (SC, or IM) was injected at a dose of 25 mg every week until clearance or for a maximum of 8 sessions.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Reduction in size and number of tumors
时间窗: up to 1 month after the last session
Patients were divided into 3 groups: responders (if the tumor has regressed by \> 50%), partial responders (tumor regression \< 50%), and non- responders (no improvement at all or worsening).
次要结局
- New NMSC lesions elsewhere(from the start of the study and till the end of follow up period (6 months))
- Adverse effects(Starting from the first session and up to 6-months after the last session)
- Recurrence(till the end of follow up duration (6 months))
研究者
Basma Magdy Elkholy, MD
Dr
Zagazig University