Randomized Phase II study comparing FLASH radiotherapy treatment versus conventional radiotherapy treatment in patients with localized squamous cell carcinoma or basal cell carcinoma.
Summary description of the study
This radiotherapy study plans to include 60 patients who will be divided into two groups according to a randomization process: each patient will have an equal chance of receiving high-dose radiotherapy or conventional radiotherapy. The size of the lesions to be treated will determine the treatment schedule: for small lesions, radiotherapy will be administered once, while for each large lesion a total of five doses will be administered over a period of two weeks.
(BASEC)
Intervention under investigation
High-dose radiotherapy and conventional radiotherapy.
(BASEC)
Disease under investigation
Localized cutaneous squamous cell carcinoma and basal cell carcinoma
(BASEC)
1) Patients over 60 years old 2) Patients with inoperable cutaneous squamous cell carcinoma or basal cell carcinoma, or for whom the patient has refused surgical treatment. 3) The size of each lesion to be treated must be ≤ 4 cm in diameter 4) Lesions must be at least 4 cm apart if treated with 2 different modalities (including surgical treatment) (BASEC)
Exclusion criteria
1) Lesions have already been treated with radiotherapy 2) The patient has an autoimmune disease with skin lesions 3) The patient is receiving radiosensitizing medications 3) The patient is receiving anticancer medications to treat another tumor (BASEC)
Trial sites
Lausanne
(BASEC)
Sponsor
CHUV as represented by Prof. Fernanda Herrera
(BASEC)
Contact
Contact Person Switzerland
Prof. Olivier Gaide
+41 21 314 01 11
olivier.gaide@clutterchuv.chCHUV
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
(BASEC)
Date of authorisation
01.12.2022
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Randomized phase II selection trial of FLASH versus conventional radiotherapy for patients with localized cutaneous squamous cell carcinoma or basal cell carcinoma (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available