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Trial Title:
FLASH Radiotherapy for Skin Cancer
NCT ID:
NCT05724875
Condition:
Basal Cell Carcinoma
Cutaneous Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Conditions: Keywords:
FLASH therapy
basal cell carcinoma
cutaneous squamous cell carcinoma
high dose rate radiotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
FLASH RT
Description:
For T1 (small) lesions: 22 Gy single dose FLASH RT; For T2 (large) lesions: 5 x 6 Gy
fractionated dose FLASH RT
Arm group label:
Arm A: FLASH RT
Other name:
High dose rate radiotherapy
Intervention type:
Device
Intervention name:
Conventional RT
Description:
For T1 (small) lesions: 22 Gy single dose conventional RT; For T2 (large) lesions: 5 x 6
Gy fractionated dose conventional RT
Arm group label:
Arm B: Conventional RT
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier Universitaire Vaudois (CHUV)
Address:
City:
Lausanne
Zip:
1011
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Olivier Gaide, MD, PhD
Phone:
0041213140111
Email:
olivier.gaide@chuv.ch
Start date:
June 22, 2023
Completion date:
September 2026
Lead sponsor:
Agency:
Centre Hospitalier Universitaire Vaudois
Agency class:
Other
Source:
Centre Hospitalier Universitaire Vaudois
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05724875
