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临床试验 NCT07455331 (LANCE) 针对Cutaneous Squamous Cell Carcinoma (CSCC)，Basal Cell Carcinoma (BCC)目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
Flash Radiotherapy for Skin Cancer (LANCE) II期 60 单次给药
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临床试验NCT07455331 (LANCE)旨在研究治疗，主要针对Cutaneous Squamous Cell Carcinoma (CSCC)，Basal Cell Carcinoma (BCC)。这是一项II期 干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年3月23日开始，预计招募60名患者。该研究由Jules Bordet Institute主导，计划于2030年12月23日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月6日。
简要概括
The goal of this clinical investigation is to describe and compare the toxicity and efficacy of an experimental radiotherapy, named FLASH therapy, to conventional radiotherapy for subjects suffering from localized Cutaneous Squamous Cell Carcinoma (cSCC) and Basal Cell Carcinoma (BCC). FLASH therapy can deliver the irradiation dose within milliseconds instead of the minutes commonly required in conventional radiother...显示更多
官方标题
Randomized Phase II Selection Trial of FLASH Versus Conventional Radiotherapy for Participants With Localized Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma
疾病
Cutaneous Squamous Cell Carcinoma (CSCC)Basal Cell Carcinoma (BCC)其他研究标识符
- LANCE
- IJB-LANCE-2025
NCT编号
实际开始日期
2026-03-23
最近更新发布
2026-03-06
预计完成日期
2030-12-23
计划入组人数
60
研究类型
干预性研究
试验分期 (阶段)
II期
试验状态
尚未招募
关键词
radiotherapy
FLASH
skin cancer
FLASH
skin cancer
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性FLASH radiotherapy 22 Gy single dose FLASH radiotherapy | FLASH radiotherapy FLASH therapy is delivered almost instantaneously (in milliseconds), as opposed to conventional radiotherapy, which is delivering the dose in minutes. |
阳性对照Conventional radiotherapy 22 Gy single dose conventional radiotherapy | 常规放疗 Standard of Care |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Evaluate the safety of FLASH radiotherapy | Safety of FLASH radiotherapy measured by the collection of ≥ grade 3 skin toxicity AEs (CTCAE v6.0) ≤ 6 weeks after radiotherapy. Assessment will be performed by physical examination at 3,4,6 weeks post treatment (It may be necessary to perform these procedures at unscheduled time points if deemed clinically necessary by the investigator). | "From enrollment until 6 weeks after radiotherapy" |
hierarchically tested efficacy of FLASH radiotherapy | Hierarchically tested efficacy measured by local control rate at 1-year. Local control rate is censured by any in field local relapse up to one-year post randomization (Tumor response evaluated during physical exam). Assessment will be performed by physical exam and Blinded Imaging Central Review (BICR) of photographs at 3,4,6 weeks and 3,6,12 months. | "From enrollment until 1-year post randomization" |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Evaluate tumor response | Tumor response Assessment will be performed by physical exam and Blinded Imaging Central Review (BICR) of photographs at 3,4,6 weeks and 3,6,12 months post treatment | "From enrolment until 12 months post-treatment" |
Evaluate acute side effects "in the radiation field" | Acute side effects "in the radiation field" defined by any toxicity (CTCAE v6.0), until 3 months after the irradiation date. Assessment will be performed by physical exam, Blinded Imaging Central Review (BICR) of photographs at 3,4,6 weeks post treatment and OCT (optical coherence tomography) at 4 weeks post treatment. | "From enrollment until 6 weeks after the irradiation date" |
Evaluate late side effects "in the radiation field" | Late side effects "in the radiation field" (within 3 to 12 months post-treatment) (CTCAE v6.0). Assessment will be performed by physical exam, Blinded Imaging Central Review (BICR) of photographs 3,6,12 months post treatment and OCT (optical coherence tomography) at 6 and 12 months. | "From 3 months post treatment until 12 months post treatment" |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
60 Years
适龄性别
全部
- Signed study Informed Consent Form
- Karnofsky Performance Status (KPS) ≥ 60
- Age ≥ 60 years
- Participants with histologically proven cSCC; or participants with BCC either histologically proven or proven by non-invasive imaging: either OCT, LC-OCT or RCM
- Participants requiring radiotherapy treatment according to the dermato-oncology tumor board: participants who cannot undergo surgical procedure or participants who decline surgical resection, and/or anatomical locations where surgery can compromise function or cosmesis.
- T1-N0 lesions (TNM UICC, 8th Edition)
- Lesions should be at least 4 cm apart if treated with 2 different modalities (including surgical treatment of lesions). Lesions should not be located on the face, except on the forehead, above a line situated 1 cm above the eyebrows. Lesions located on the scalp can be treated
- In cases of prior intervention within the target area, the treated lesion must be located at a distance of > 4 cm from the previous site.
- Previous radiotherapy in the treated area or a history of radiation therapy within 4 cm of the lesion to be treated
- Concomitant auto-immune disease with skin lesions
- Concomitant use of radio-sensitizer drug
- Cognitive disorders not compatible with the signature of informed consent or that may compromise compliance with the requirements of the study
- Current, recent (within 10 days prior to start of study treatment), or planned participation in an experimental drug study (before EOT visit)
- Concomitant use of systemic or immunochemotherapy for skin cancer(s)
- Concomitant use of systemic chemotherapy for a cancer other than the skin cancer(s)
- Topical antitumoral treatment is prohibited within the radiation field except after a mandatory 4-weeks washout period.
- Any active cutaneous infection within the irradiation field (except if completely resolved prior to the initiation of radiotherapy).
- Uncontrolled intercurrent comorbidities that may impair wound healing including Diabetes Mellitus (HbA1c > 8.5% or evidence of active diabetic ulceration), Chronic Venous Insufficiency with active venous ulcers, or severe (Grade 3+) oedema in the treatment field.
Jules Bordet Institute研究中心联系人
联系人: Antoine Desmet, Dr, +32 2 5413032, [email protected]
联系人: Sophie Lepannetier, PhD, +32 02 541 3456, [email protected]
1 位于 1 个国家/地区的研究中心
Anderlecht
Institut Jules Bordet, Brussels, Anderlecht, 1070, Belgium