Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract

Recruiting now · Not applicable

Conditions studied: Malignant Melanoma, Gynecologic Cancer

In brief

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).

Key facts

Study ID

NCT05478876

Run by

CNAO National Center of Oncological Hadrontherapy

People needed

9

Starts

2020-09-03

Expected to finish

2027-09-01

Last updated by the study team

2024-08-21

Who can join

Age: 20 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

• CNAO — Pavia, Italy (enrolling)

Full record on ClinicalTrials.gov

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