RecruitingNot ApplicableNCT05478876

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

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"

Sponsor

CNAO National Center of Oncological Hadrontherapy

Enrollment

9 participants

Start Date

Sep 3, 2020

Study Type

INTERVENTIONAL

Conditions

Gynecologic Cancer Malignant Melanoma

Summary

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).

Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing carbon ion radiation therapy — a more precise and powerful form of radiation — for women with rare melanoma tumors in the lower female genital tract (such as the vagina or vulva). This type of cancer is difficult to treat, and carbon ion therapy may offer better targeting with less damage to surrounding tissue. **You may be eligible if...** - You are a woman between 20 and 80 years old - You have been diagnosed with mucosal melanoma of the lower female genital tract, confirmed by biopsy - The cancer has not spread to distant organs - The tumor is at least 5mm away from the rectum and bladder - You have not previously received radiation therapy to this area - Your general health status is adequate (ECOG 0–2) **You may NOT be eligible if...** - You have metal implants (like hip prostheses) that would interfere with imaging or treatment planning - You are pregnant or breastfeeding - You have had another invasive cancer in the past 3 years - You cannot have an MRI scan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONcarbon ion radiation therapy CIRT

CIRT: The low-dose CTV (clinical target volume) will receive a total dose of 43 GyRBE in 10 fractions, 4 fractions per week. The high-dose CTV will receive a total dose of 68.8 GyRBE in 16 fractions, 4 fractions per week. The expected duration of treatment is 4 weeks, 4 fractions per week. Treatments lasting longer than 6 weeks, or with less than 6 fractions administered on 14 consecutive days, will not be considered acceptable. Immunotherapy: Patients will undergo immunotherapy after carbon ion radiation therapy (CIRT) up to maximum response and/or up to tolerance. The concomitant association of immunotherapy is not envisaged in this protocol.