FLASH Radiotherapy for Skin Cancer

Basal Cell Carcinoma Clinical Trial

— LANCE  

Official title:

Randomized Phase II Selection Trial of FLASH Versus Conventional Radiotherapy for Patients With Localized Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05724875
• Other study ID #: CHUV-DO-0024-LANCE-2020
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2023
• Est. completion date: September 2026

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Lana Kandalaft, Pharm D, PhD
• Phone: +41 79 556 39 15
• Email: lana.kandalaft[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Signed study Informed Consent Form
• Karnofsky Performance Status (KPS) = 60
• Age = 60 years
• Patients with histologically proven cSCC or BCC
• 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.

Exclusion Criteria:

• 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 oncological treatment for a cancer other than the skin cancer(s)

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Squamous Cell
• Cutaneous Squamous Cell Carcinoma

Intervention

Device:
• FLASH RT
For T1 (small) lesions: 22 Gy single dose FLASH RT; For T2 (large) lesions: 5 x 6 Gy fractionated dose FLASH RT
• Conventional RT
For T1 (small) lesions: 22 Gy single dose conventional RT; For T2 (large) lesions: 5 x 6 Gy fractionated dose conventional RT

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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: 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	From Day 1 up to 12 months post-treatment
Secondary	Frequency of acute side effects observed "in radiation field"		up to 3 months after radiotherapy
Secondary	Frequency of late side effects observed "in radiation field"		from = 3 months after radiotherapy until 12 months post-treatment start
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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