Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract
Recruiting · NCT05478876 · Interventional (participants receive a specific treatment) · Lead sponsor: CNAO National Center of Oncological Hadrontherapy
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Inclusion criteria
- Histological diagnosis
- Absence of skin extension
- N + (only if confined to the groin and pelvis)
- Age between 20-80 years
- ECOG 0-2
- No evidence of metastasis
- At least 5 mm away with rectum and bladder wall
- No previous RT
- Written informed consent
- Patient's ability to understand the characteristics and consequences of the clinical trial
- Molecular characterization/ mutational state
- Disease staging (baseline exams)
Exclusion criteria
- Hip prosthesis, or metal prostheses or any other condition that prevents adequate imaging to identify the target volume and calculate the dose in the treatment plan
- Psychic or other disorders that may prevent informed consent
- Previous invasive tumor unless patient has been disease free for at least 3 years
- Contraindication to MRI
- Pregnancy or breastfeeding in progress
Where it is running
1 location listed.
- CNAO - Pavia, Italy