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临床试验/NCT05561634
NCT05561634招募中2 期

Evaluation of Radiotherapy After Complete Response to Sonic Hedgehog Pathway Inhibitors in Patients With Locally Advanced Basal Cell Carcinoma: a Prospective Multicenter Study

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2023年6月20日最近更新:
适应症
干预措施
相关药物

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

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

Sham Comparator

干预措施: Radiotherapy (Radiation)

SHHI then follow-up

Sham Comparator

干预措施: Observation (Other)

SHHI then radiotherapy

Experimental

干预措施: Radiotherapy (Radiation)

SHHI then radiotherapy

Experimental

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)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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