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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: FLASH RT | Experimental |
| |
| Arm B: Conventional RT | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLASH RT | Device | For T1 (small) lesions: 22 Gy single dose FLASH RT; For T2 (large) lesions: 5 x 6 Gy fractionated dose FLASH RT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of ≥ grade 3 skin toxicity adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | 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. | up to 6 weeks after radiotherapy |
| Hierarchically tested efficacy measured by local control rate | 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:
| From Day 1 up to 12 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of acute side effects observed "in radiation field" | up to 3 months after radiotherapy | |
| Frequency of late side effects observed "in radiation field" | from ≥ 3 months after radiotherapy until 12 months post-treatment start |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Gaide, MD, PhD | Centre Hospitalier Universitaire Vaudois | Principal Investigator |
| Jean Bourhis, MD, PhD | Centre Hospitalier Universitaire Vaudois | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | Canton of Vaud | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Conventional RT | Device | For T1 (small) lesions: 22 Gy single dose conventional RT; For T2 (large) lesions: 5 x 6 Gy fractionated dose conventional RT |
|
| Evaluation of tumor response | Blinded Imaging Central Review (BICR) of photographs will evaluate tumor response by grading the size of the residual tumor in comparison to the size of the tumor on the day of irradiation (in percentage). 0% means no residual tumor and treatment success, 100% or more indicate a total lack of tumor response. A baseline photograph will be taken the day of the treatment (day 1) in a pre-therapeutic setting with skin delineation of the lesion. Then photos will be repeated at day 21 (+/-2d), day 28 (+/-2d), day 42 (+/-3d) after treatment, then at 3 (+/-7d), 6 (+/-14d), 12 (+/-14d) months after treatment, and at progression. | From Day 1 up to 12 months post-treatment |
| Evaluation of "in radiation field" normal tissues reaction around the treated tumors | Blinded Imaging Central Review (BICR) of photographs will evaluate "in radiation field" normal tissues reaction around the treated tumors by grading radiation induced skin reactions, grade 1-5, using the CTCAE scale. A baseline photograph will be taken the day of the treatment (day 1) in a pre-therapeutic setting with skin delineation of the lesion. Then photos will be repeated at day 21 (+/-2d), day 28 (+/-2d), day 42 (+/-3d) after treatment, then at 3 (+/-7d), 6 (+/-14d), 12 (+/-14d) months after treatment, and at progression. | From Day 1 up to 12 months post-treatment |
| Epidermis thickness measured by Optical coherence tomography (OCT) | Epidermis thickness in micrometer will be measured by OCT and compared between irradiated skin and normal non-irradiated skin | at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment |
| Epidermis roughness measured by OCT | Epidermis roughness in micrometer will be measured by OCT and compared between irradiated skin and normal non-irradiated skin | at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment |
| Plexus depth measured by OCT | Plexus depth in micrometer will be measured by OCT and compared between irradiated skin and normal non-irradiated skin | at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment |
| Vessel density measured by OCT | Vessel density, expressed as percent of the surface covered by the vessels in the examined area, will be measured by OCT and compared between irradiated skin and normal non-irradiated skin | at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment |
| Size of vessels measured by OCT | Mean size (in micrometer) of all vessels in the examined area will be measured by OCT and compared between irradiated skin and normal non-irradiated skin | at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment |
| Number of hairs counted by OCT | Number of hairs in the examined area will be counted by OCT and compared between irradiated skin and normal non-irradiated skin | at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment |
| Size of hairs measured by OCT | Mean size (in micrometer) of all hairs in the examined area will be measured by OCT and compared between irradiated skin and normal non-irradiated skin | at baseline, at 4 weeks, at 6 months, and at 12 months post-treatment |
| D018295 |
| Neoplasms, Basal Cell |