Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer: Study Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Rate of complete remission with hypofractionated RT schemes for NMSC.
研究概览
简要总结
Radiotherapy is a treatment considered standard for non melanoma skin cancer. This institution uses schemes of 4 to 6 weeks of treatment. The objective of the study is to perform radiation therapy in 1 to 2 weeks, depending on the size of the lesion.
详细描述
Delineation of radiation field
- Gross tumor volume (GTV): disease clinically visible / palpable
- clinical target volume (CTV): equal to GTV
- planned treatment volume (PTV):
- tumors ≤ 2 cm in diameter, with 5-10 mm CTV margin
- tumors> 2-5 cm in diameter, with 15-20 mm CTV margin
- Marking the GTV and PTV pen back projection
- photograph of the treatment area
- protections of the normal structures with blocks of lead, if necessary
Technical
- Distance focus-skin Tube: 35 cm Locator: 30 and 40 cm
- Sizes Tube: 2, 3 and 4 cm in diameter Finder: 6x8 cm, 8x10 cm
- Energy:
80 kV 140 kv
- Filter 80 kV, 2 mm Al 140 kv, 0.5 mm Copper
- Current Draw: 20 mA
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Cosmesis not important
- •Basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of any differentiation
- •Clinical stage I and II
- •Location on the thorax, abdomen, pelvis (except perineum), arm, thigh, cheek
- •Patient with up to 3 injuries eligible for the study
- •Karnofsky Performance Status (KPS) ≥ 70%
- •Age > 18 years
- •Informed Consent signed by the patient consenting to undergo the study
排除标准
- •Indian Race
- •Prior treatment for their skin cancer
- •More than three synchronous lesions to treatment with RT
- •Basal syndrome, xeroderma, vitiligo and albinism
- •Immunosuppression
- •Prior burn at the tumor site
- •Tumor > 5 cm
- •Age <18 years
- •Carrier mental incapacity
- •People in a relationship of dependence as prisoners, soldiers, students, staff, etc..
结局指标
主要结局
Rate of complete remission with hypofractionated RT schemes for NMSC.
时间窗: Second week and twelfth week after initiation of radiotherapy
RECIST criteria * Complete Response: disappearance of the lesion * Partial Response: Reduction ≥ 30% of the larger initial diameter of the lesion * Progressive Disease: ≥ 20% increase in the largest initial diameter of the lesion * Stable disease: not increase enough to consider disease progression or reduction sufficient to consider a partial response.
次要结局
- Quality of Life(Second week and twelfth week after initiation of radiotherapy)
- Toxicity(Second week and twelfth week after initiation of radiotherapy)