NCT05478876 Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract
| NCT ID | NCT05478876 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CNAO National Center of Oncological Hadrontherapy |
| Condition | Malignant Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2020-09-03 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 9 participants in total. It began in 2020-09-03 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Amelia Barcellini, MD
PRINCIPAL INVESTIGATOR
CNAO National Center of Oncological Hadrontherapy
Frequently Asked Questions
Who can join the NCT05478876 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 80 Years, studying Malignant Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05478876 currently recruiting?
Yes, NCT05478876 is actively recruiting participants. Contact the research team at amelia.barcellini@cnao.it for enrollment information.
Where is the NCT05478876 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT05478876 clinical trial?
NCT05478876 is sponsored by CNAO National Center of Oncological Hadrontherapy. The principal investigator is Amelia Barcellini, MD at CNAO National Center of Oncological Hadrontherapy. The trial plans to enroll 9 participants.
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