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

Launched by CNAO NATIONAL CENTER OF ONCOLOGICAL HADRONTHERAPY · Jul 27, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called carbon ion radiation therapy for women with mucous melanomas in the lower genital tract. Melanomas are a type of skin cancer, but in this case, they are located in the mucous membranes. The goal of the study is to see if this specialized radiation can help patients live longer without their cancer getting worse and to effectively control the cancer in the targeted area. Unlike traditional radiation, carbon ion therapy may be more effective against these tough cancers and can better protect surrounding healthy tissues.

To participate in this trial, women aged 20 to 80 who have been diagnosed with mucous melanoma may be eligible, provided they have no skin involvement and their disease is localized. Participants will need to provide written consent and undergo certain tests to ensure they meet the study requirements. Throughout the trial, they can expect to receive the carbon ion treatment and will be monitored closely for how well it works and any side effects. It's important to know that while this study focuses on the new radiation therapy, patients may still receive other treatments like immunotherapy if needed.

Gender

FEMALE

Eligibility criteria

• 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