Irradiation of Melanoma in a Pulse

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastasis From Malignant Melanoma of Skin (Diagnosis)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Dose escalation study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose escalation of FLASH therapy in skin metastases of small volume (≤ 30 cc)

7 dose levels (22 Gy; 24 Gy; 26 Gy; 28 Gy, 30 Gy, 32 Gy and 34 Gy)

Group Type EXPERIMENTAL

FLASH therapy

Intervention Type DEVICE

Dose escalation of high dose rate radiotherapy (FLASH therapy) as single dose treatment for skin melanoma metastases that progress locally despite systemic treatments.

Dose escalation of FLASH therapy in skin metastases of large volume (> 30 and ≤ 100 cc)

7 dose levels (22 Gy; 24 Gy; 26 Gy; 28 Gy, 30 Gy, 32 Gy and 34 Gy)

Group Type EXPERIMENTAL

FLASH therapy

Intervention Type DEVICE

Dose escalation of high dose rate radiotherapy (FLASH therapy) as single dose treatment for skin melanoma metastases that progress locally despite systemic treatments.

Interventions

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FLASH therapy

Dose escalation of high dose rate radiotherapy (FLASH therapy) as single dose treatment for skin melanoma metastases that progress locally despite systemic treatments.

Intervention Type DEVICE

Other Intervention Names

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high dose rate radiotherapy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No