Randomized Phase II Selection Trial of FLASH Versus Conventional Radiotherapy for Patients with Localized Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Hierarchically tested efficacy measured by local control rate
研究概览
简要总结
This is a single center randomized selected Phase II study of FLASH radiotherapy (RT) versus standard of care (SOC) radiotherapy in patients with localized Cutaneous Squamous Cell Carcinoma (cSCC) or Basal Cell Carcinoma (BCC).
In summary, the aims of the study are to describe and compare the toxicity and efficacy of high dose rate radiotherapy (FLASH therapy) to SOC conventional radiotherapy (according to the standard guidelines per lesion size) through a randomized Phase II selection study in patients presenting localized cSCC or BCC requiring a radiotherapy 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
- None
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
- •Patients with histologically proven cSCC or patients with BCC either histologically proven or proven by non-invasive imaging: either Optical Coherence Tomography (OCT), Line-field OCT (LC-OCT) or Reflectance Confocal Microscopy (RCM)
- •Patients requiring radiotherapy treatment according to the dermato-oncology tumor board: patients who cannot undergo surgical procedure or patients who decline surgical resection, and/or anatomical locations where surgery can compromise function or cosmesis.
- •T1-T2 N0 lesions with a small (T1; lesion ≤ 2cm in diameter) or large (T2; 2cm < lesion ≤ 4 cm) volume (TNM Classification of Malignant Tumours (TNM) Union for International Cancer Control (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.
排除标准
- •Previous radiotherapy in the treated area
- •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 end of treatment (EOT) visit)
- •Concomitant use of systemic chemotherapy for a cancer other than the skin cancer(s)
结局指标
主要结局
Hierarchically tested efficacy measured by local control rate
时间窗: From Day 1 up to 12 months post-treatment
At day 1, 21, 28, 42, and months 3, 6, and 12 post-treatment, the investigator will measure (with a caliper) the largest diameter of selected lesions for irradiation. Tumor response of each irradiated lesion will be assessed by the investigator as follow: * Complete Response: the irradiated lesion is no more visualized * Partial Response: the irradiated largest lesion dimension decreased by 30% at least from baseline (day 1) * Progressive Disease: the irradiated largest lesion dimension increased by 20% at least from baseline (day 1) * Stable Disease: no Complete Response, no Partial Response, no Progressive Disease
Frequency of ≥ grade 3 skin toxicity adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
时间窗: up to 6 weeks after radiotherapy
To evaluate the safety of FLASH radiotherapy measured by the collection of ≥ grade 3 skin toxicity AEs according to CTCAE version 5.0. The severity of a specific event is graded i.e. mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4), or death (grade 5) using the CTCAE Grading Table.
次要结局
- Frequency of late side effects observed "in radiation field"(from ≥ 3 months after radiotherapy until 12 months post-treatment start)
- Vessel density measured by OCT(at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment)
- Number of hairs counted by OCT(at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment)
- Evaluation of tumor response(From Day 1 up to 12 months post-treatment)
- Epidermis thickness measured by Optical coherence tomography (OCT)(at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment)
- Plexus depth measured by OCT(at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment)
- Size of hairs measured by OCT(at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment)
- Epidermis roughness measured by OCT(at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment)
- Size of vessels measured by OCT(at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment)
- Frequency of acute side effects observed "in radiation field"(up to 3 months after radiotherapy)
- Evaluation of "in radiation field" normal tissues reaction around the treated tumors(From Day 1 up to 12 months post-treatment)
研究者
Prof. Olivier Gaide, MD-PhD
Prof, MD, PhD
Centre Hospitalier Universitaire Vaudois