Actively Recruiting
Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract
Led by CNAO National Center of Oncological Hadrontherapy · Updated on 2024-08-21
9
Participants Needed
1
Research Sites
364 weeks
Total Duration
On this page
AI-Summary
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).
CONDITIONS
Official Title
Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of mucosal melanoma
- No extension of melanoma to the skin
- Lymph node involvement only if limited to groin and pelvis
- Age between 20 and 80 years
- ECOG performance status of 0 to 2
- No evidence of metastasis
- Tumor at least 5 mm away from rectum and bladder wall
- No previous radiotherapy
- Written informed consent provided
- Ability to understand the clinical trial's characteristics and consequences
- Molecular tumor characterization and mutational status available
- Disease staging completed with baseline exams
You will not qualify if you...
- Presence of hip prosthesis, metal prostheses, or any condition preventing proper imaging for treatment planning
- Psychiatric or other disorders preventing informed consent
- Previous invasive tumor unless disease-free for at least 3 years
- Contraindication to MRI
- Current pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CNAO
Pavia, Italy, 27100
Actively Recruiting
Research Team
A
Amelia Barcellini, MD
CONTACT
C
Cristina Bono, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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