Clinical trial · Interventional
Irradiation of Melanoma in a Pulse
A Phase I, First-in-human, Dose Finding Study of High Dose Rate Radiotherapy in Patients With Skin Metastases From Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single center phase I, first-in-human, dose escalation study of FLASH therapy in patients with metastases of melanoma. The trial is based on escalating single doses of FLASH therapy administered to skin melanoma metastases using the Mobetron® with high dose rate (HDR) functionality. The aim of the study is to evaluate a dose escalation of high dose rate radiotherapy (FLASH therapy) as single dose treatment for skin melanoma metastases that progress locally despite systemic treatments. Melanoma is a typically radio-resistant tumor type, which can justify such a dose escalation with a new type of radiotherapy that appears much better tolerated than conventional radiotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastasis From Malignant Melanoma of Skin (Diagnosis) | Melanoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FLASH therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose escalation of FLASH therapy in skin metastases of small volume (≤ 30 cc)
- description
- 7 dose levels (22 Gy; 24 Gy; 26 Gy; 28 Gy, 30 Gy, 32 Gy and 34 Gy)
- interventionNames
- Device: FLASH therapy
- type
- EXPERIMENTAL
- label
- Dose escalation of FLASH therapy in skin metastases of large volume (> 30 and ≤ 100 cc)
- description
- 7 dose levels (22 Gy; 24 Gy; 26 Gy; 28 Gy, 30 Gy, 32 Gy and 34 Gy)
- interventionNames
- Device: FLASH therapy
Primary outcomes (1)
- measure
- Determination of maximum tolerated dose (MTD) or recommended phase II dose (RP2D), separately for skin metastases of small and large volumes.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed study Informed Consent Form 2. Karnofsky Performance Status (KPS) ≥ 50 3. Age ≥ 18 years 4. Patients with metastatic melanoma and multiple skin metastases with a documented clinical progression despite the systemic treatments (chemotherapy, and/or Programmed cell death 1 (PD1), cytotoxic T-lymphocyte antigen-4 (CTLA4) inhibitors or tyrosine kinase inhibitors (TKIs), such as v-raf murine sarcoma viral oncogene homolog B1 (BRAF) or mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors) 5. The size of the treated lesions should be ≤ 5.5 cm in diameter and ≤ 2.8 cm thick (caliper-based measurement) 6. The treated lesions should be at least 5 cm apart and must not be located on the face. 7. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (urine or serum) during screening 8. WOCBP must use a contraceptive method Exclusion Criteria: 1. Previous radiotherapy in the treated area 2. Concomitant auto-immune disease with skin lesions 3. Concomitant use of radio-sensitizer drug 4. Women who are pregnant 5. Current, recent (within 10 days prior start of study treatment), or planned participation in an experimental drug study. During the 4 weeks DLT period, the patient will not be able to participate to any other clinical study. 6. Any serious underlying medical condition that could interfere with study treatment and potential adverse events 7. Any mental or other impairment that may compromise compliance with the requirements of the study
References
Publications (1)
- DERIVEDMaity A, Koumenis C. Shining a FLASHlight on Ultrahigh Dose-Rate Radiation and Possible Late Toxicity. Clin Cancer Res. 2022 Sep 1;28(17):3636-3638. doi: 10.1158/1078-0432.CCR-22-1255. PMID 35736814