Carbon ion radiation therapy for treating mucous melanomas in the female lower genital tract
Official title: 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"
Run by CNAO National Center of Oncological Hadrontherapy · NCT05478876 · Data updated 2026-11-12
This study is testing if carbon ion radiation therapy can help women with non-metastatic mucosal melanoma in the lower genital tract who can't have surgery, to see if it works better than standard treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 80 Years |
| Sex | Women only |
| Enrollment | 9 (estimated) |
| Sponsor | CNAO National Center of Oncological Hadrontherapy Academic / other |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 1 site (Pavia) |
| Status | Recruiting |
| Started | September 3, 2020 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | August 21, 2024 |
| Trial ID | NCT05478876 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 20-80 with a histological diagnosis of non-metastatic gynaecological melanoma who have not undergone previous radiotherapy.
✕Probably not a fit
Patients with metastatic disease, previous invasive tumors within the last three years, or those unable to provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of carbon ion radiation therapy (CIRT) in patients with non-metastatic mucosal melanoma of the lower genital tract who are not suitable for surgery. The study aims to achieve improved progression-free survival and local control rates compared to traditional treatments. Participants will undergo baseline examinations followed by CIRT, with the option for immunotherapy in a sequential manner. The response to treatment will be evaluated using RECIST criteria.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and local control for patients with a challenging form of cancer.
How similar studies have gone: Other studies have shown promising results with carbon ion therapy in treating radio-resistant tumors, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Cnao
Pavia, Italy Recruiting
Study contacts
- Principal investigator: Amelia Barcellini, MD — CNAO National Center of Oncological Hadrontherapy
- Study coordinator: Amelia Barcellini, MD
- Email: amelia.barcellini@cnao.it
- Phone: 0039 0382078501
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.