Carbon ion radiation therapy for treating mucous melanomas in 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"
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | Female |
| Sponsor | CNAO National Center of Oncological Hadrontherapy Academic / other |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 1 site (Pavia) |
| Trial ID | NCT05478876 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 20-80 with a histological diagnosis of non-metastatic gynaecological melanoma who have not undergone previous radiotherapy.
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.
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 performed: Other studies have shown promising results with carbon ion therapy in treating radio-resistant tumors, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Pavia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.