Evaluation of Radiotherapy After Complete Response to Sonic Hedgehog Pathway Inhibitors in Patients With Locally Advanced Basal Cell Carcinoma: a Prospective Multicenter Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Occurrence of a local relapse at 2 years in both groups.
研究概览
简要总结
Locally advanced basal cell carcinoma (BCC) are large BCCs or BCCs located in areas subject to functional and aesthetic risk following surgery or radiotherapy. In these particular situations, surgery and radiotherapy are sometimes not appropriate, and Sonic Hedgehog inhibitors (SHHi) (Vismodegib and Sonidegib) can be proposed. SHHi are effective treatments in laBCC but most CR patients discontinue treatment because of tolerability. Approximately 65% of the population experience a relapse after discontinuation. A few cases of patients treated concomitantly by radiotherapy and vismodegib have been reported in the literature, suggesting that combining vismodegib and concomitant radiotherapy results in an improved overall response compared to a single modality treatment. There is no study evaluating a "consolidation radiotherapy" after complete response to SHHi. We carry out a prospective multicenter study in order to evaluate consolidation radiotherapy in patients with laBCC after achieving complete response with SHHi, with the hypothesis of reducing recurrence after discontinuation of SHHi.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patient over 18 years
- •Locally advanced non-recurrent BCC in complete response after first course of SHHi
- •Complete response has to be confirmed histologically
- •Available photography or CT scan before SHHi treatment allowing delineation of the initial tumor
排除标准
- •Patients with distant metastasis
- •Patients with Gorlin's syndrome
- •Prior radiotherapy to the region of the studied cancer that would result in overlap of radiation therapy fields
- •Pregnant women
- •Life expectancy less than 1 year
- •Inability to receive informed consent
- •Inability to participate in the entire study
- •Lack of social security coverage
- •Refusal to sign consent
研究组 & 干预措施
SHHI then follow-up
干预措施: Radiotherapy (Radiation)
SHHI then follow-up
干预措施: Observation (Other)
SHHI then radiotherapy
干预措施: Radiotherapy (Radiation)
SHHI then radiotherapy
干预措施: Vismodegib (Drug)
结局指标
主要结局
Occurrence of a local relapse at 2 years in both groups.
时间窗: At 2 years
次要结局
- Occurrence of local relapse at 1 and 3 years.(at 1 year and at 3 years)
- Occurrence of adverse effects in the radiotherapy group.(at 1 year, at 2 years and at 3 years)
