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Flash Radiotherapy for Skin Cancer

ConditionsCutaneous Squamous Cell Carcinoma (CSCC)Basal Cell Carcinoma (BCC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorJules Bordet Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed study Informed Consent Form

Karnofsky Performance Status (KPS) ≥ 60

Age ≥ 60 years

Participants with histologically proven cSCC; or participants with BCC either histologically proven or proven by non-invasive imaging: either OCT, LC-OCT or RCM

Disqualifiers

Previous radiotherapy in the treated area or a history of radiation therapy within 4 cm of the lesion to be treated

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • FLASH radiotherapy

    Radiation

    FLASH therapy is delivered almost instantaneously (in milliseconds), as opposed to conventional radiotherapy, which is delivering the dose in minutes.

  • Conventional radiotherapy

    Radiation

    Standard of Care

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: FLASH radiotherapyExperimental treatment 1 intervention
Group B: Conventional radiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
"From enrollment until 6 weeks after radiotherapy"
2

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.

Time frame
"From enrollment until 1-year post randomization"

Secondary outcomes

1

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

Time frame
"From enrolment until 12 months post-treatment"
2

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.

Time frame
"From enrollment until 6 weeks after the irradiation date"
3

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.

Time frame
"From 3 months post treatment until 12 months post treatment"

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jules Bordet Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: