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De klinische studie NCT07455331 (LANCE) voor Cutaneous Squamous Cell Carcinoma (CSCC), Basal Cell Carcinoma (BCC) is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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Flash Radiotherapy for Skin Cancer (LANCE) Fase 2 60 Enkele dosis

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De klinische studie NCT07455331 (LANCE) onderzoekt behandeling bij Cutaneous Squamous Cell Carcinoma (CSCC), Basal Cell Carcinoma (BCC). Deze Fase 2 interventioneel studie heeft de status nog niet rekruterend. De inclusie van 60 deelnemers begint op 23 maart 2026. De studie wordt geleid door Jules Bordet Institute en de voltooiing is gepland op 23 december 2030. Laatste update op ClinicalTrials.gov: 6 maart 2026.
Beknopte samenvatting
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 radiother...Toon meer
Officiële titel

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

Aandoeningen
Cutaneous Squamous Cell Carcinoma (CSCC)Basal Cell Carcinoma (BCC)
Andere studie-ID's
  • LANCE
  • IJB-LANCE-2025
NCT-ID
NCT07455331
Startdatum (Werkelijk)
2026-03-23
Laatste update geplaatst
2026-03-06
Verwachte einddatum
2030-12-23
Inschrijving (Geschat)
60
Studietype
Interventioneel
FASE
Fase 2
Status
Nog niet rekruterend
Trefwoorden
radiotherapy
FLASH
skin cancer
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Enkelblind
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelFLASH radiotherapy
22 Gy single dose FLASH radiotherapy
FLASH radiotherapy
FLASH therapy is delivered almost instantaneously (in milliseconds), as opposed to conventional radiotherapy, which is delivering the dose in minutes.
Actieve comparatorConventional radiotherapy
22 Gy single dose conventional radiotherapy
Conventionele radiotherapie
Standard of Care
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Evaluate the safety of FLASH 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).
"From enrollment until 6 weeks after radiotherapy"
hierarchically tested efficacy of FLASH radiotherapy
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.
"From enrollment until 1-year post randomization"
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Evaluate tumor response
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
"From enrolment until 12 months post-treatment"
Evaluate acute side effects "in the radiation field"
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.
"From enrollment until 6 weeks after the irradiation date"
Evaluate late side effects "in the radiation field"
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.
"From 3 months post treatment until 12 months post treatment"
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
60 Years
Geslachten die in aanmerking komen voor de studie
Allen
  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.

  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.
Jules Bordet Institute logoJules Bordet Institute
Centraal Contactpersoon
Contact: Antoine Desmet, Dr, +32 2 5413032, [email protected]
Contact: Sophie Lepannetier, PhD, +32 02 541 3456, [email protected]
1 Studielocaties in 1 landen

Anderlecht

Institut Jules Bordet, Brussels, Anderlecht, 1070, Belgium