Carbon ion radiation for mucosal melanoma of the female lower genital tract
Tests carbon ion radiation therapy in women with mucosal melanoma of the lower genital tract.
Plain-language title generated from the registry record
Registry title: Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract
Key facts
- Where
- Pavia, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 80 years old?
Source: NCT05478876, who can take part
Where in Italy
- CNAOPavia, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- CNAO National Center of Oncological Hadrontherapy
- Trial code
- NCT05478876
- Record updated
- 21 August 2024
- Original description
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.Read full original descriptionShow less
CNAO 40-2020 C CYCLE "Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract" "Radioterapia Con Ioni Carbonio Per il Trattamento Dei Melanomi Mucosi Ginecologici"
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).
Inclusion: 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: 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.