Condition: Malignant Melanoma · Gynecologic Cancer · Sponsor: CNAO National Center of Oncological Hadrontherapy
The present monocentric prospective phase 2 study aims to reproduce the results obtained at NIRS thus offering the possibility of obtaining a promising rate of progression-free survival (PFS) and local control (LC) in patients diagnosed with mucosal melanoma of lower genital tract. Systemic treatment with immunotherapy is not the subject of this study but is allowed both in the neoadjuvant and sequential regimens. Melanomas have always been considered poorly radiosensitive. It is now accepted that high LET (Linear Energy Transfer) particle beams, such as carbon ions, can offer a biological advantage, compared to photons treatment, in radio-resistant neoplasms treatment, thanks to their higher biological efficacy (RBE) against tumours with a low α/ ß ratio. In addition, carbon ions have the physical advantage of an inverted depth deposition profile compared to photons, allowing then a steep dose gradients that ensure increased sparing of adjacent healthy organs at risk (OARs).
This description comes directly from the study's public registry record.
Amelia Barcellini, MD · 0039 0382078501 · amelia.barcellini@cnao.it
Cristina Bono, MSc · 0382078613 · cristina.bono@cnao.it
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| CNAO | Pavia, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05478876