Basal Cell Carcinoma (BCC), Cutaneous Squamous Cell Carcinoma (CSCC)
Conditions
Keywords
radiotherapy, FLASH, skin cancer
Brief summary
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.
Interventions
RADIATIONFLASH radiotherapy
FLASH therapy is delivered almost instantaneously (in milliseconds), as opposed to conventional radiotherapy, which is delivering the dose in minutes.
RADIATIONConventional radiotherapy
Standard of Care
Sponsors
Jules Bordet Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed study Informed Consent Form 2. Karnofsky Performance Status (KPS) ≥ 60 3. Age ≥ 60 years 4. Participants with histologically proven cSCC; or participants with BCC either histologically proven or proven by non-invasive imaging: either OCT, LC-OCT or RCM 5. 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. 6. T1-N0 lesions (TNM UICC, 8th Edition) 7. 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 8. 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.
Exclusion criteria
1. Previous radiotherapy in the treated area or a history of radiation therapy within 4 cm of the lesion to be treated 2. Concomitant auto-immune disease with skin lesions 3. Concomitant use of radio-sensitizer drug 4. Cognitive disorders not compatible with the signature of informed consent or that may compromise compliance with the requirements of the study 5. Current, recent (within 10 days prior to start of study treatment), or planned participation in an experimental drug study (before EOT visit) 6. Concomitant use of systemic or immunochemotherapy for skin cancer(s) 7. Concomitant use of systemic chemotherapy for a cancer other than the skin cancer(s) 8. Topical antitumoral treatment is prohibited within the radiation field except after a mandatory 4-weeks washout period. 9. Any active cutaneous infection within the irradiation field (except if completely resolved prior to the initiation of radiotherapy). 10. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the safety of FLASH radiotherapy | "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 | "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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate tumor response | "From enrolment until 12 months post-treatment" | 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 |
| Evaluate acute side effects "in the radiation field" | "From enrollment until 6 weeks after the irradiation date" | 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. |
| Evaluate late side effects "in the radiation field" | "From 3 months post treatment until 12 months post treatment" | 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. |
Countries
Belgium
Contacts
CONTACTAntoine Desmet, Dr
CONTACTSophie Lepannetier, PhD
Outcome results
None listed