Randomized Phase II Selection Trial of FLASH Versus Conventional Radiotherapy for Participants With Localized Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluate the safety of FLASH radiotherapy
研究概览
简要总结
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 radiotherapy, with the aim of providing a curative dose while minimizing side effects on healthy tissue.
This is a phase II selection and monocentric clinical investigation with a 1 to 1 randomization. This clinical investigation will include approximately 60 participants aged ≥ 60 years old with one or more localized cSCC and BCC who either cannot undergo surgery or decline surgical resection.
The study design is the following:
- On day 1, either a single dose FLASH radiotherapy (22 Gy) will be delivered or a single dose conventional radiotherapy (22 Gy) will be delivered to the selected localized cSCC or BCC lesion(s) (up to maximum 3 per participant; all lesions distant of at least 4 cm from one-another).
- The surveillance period will be of 6 weeks post irradiation.
- Follow-up visits will take place at 3, 6, and 12 months post-treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
FLASH radiotherapy
22 Gy single dose FLASH radiotherapy
干预措施: FLASH radiotherapy (Radiation)
Conventional radiotherapy
22 Gy single dose conventional radiotherapy
干预措施: Conventional radiotherapy (Radiation)
结局指标
主要结局
Evaluate the safety of FLASH radiotherapy
时间窗: "From enrollment until 6 weeks after 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).
hierarchically tested efficacy of FLASH radiotherapy
时间窗: "From enrollment until 1-year post randomization"
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.
次要结局
- Evaluate tumor response("From enrolment until 12 months post-treatment")
- Evaluate acute side effects "in the radiation field"("From enrollment until 6 weeks after the irradiation date")
- Evaluate late side effects "in the radiation field"("From 3 months post treatment until 12 months post treatment")