NCT05478876Recruiting
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"
Source: ClinicalTrials.gov · Last updated 21 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- First submitted
- 29 Dec 2021
- Start date
- 3 Sept 2020
- Primary completion date
- Sept 2027
- Lead sponsor
- CNAO National Center of Oncological Hadrontherapy
- Diseases
- Melanoma
- NCT number
- NCT05478876
What you commit to
- Study type: Interventional
- Planned participants: 9
- From 3 Sept 2020 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Contraindication to MRI
- Pregnancy or breastfeeding in progress
Who the study is looking for
- 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)
Age in the registry: 20 years to 80 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CNAO Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.