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New treatment option for Malignant Melanoma
Official title Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract
ClinicalTrials.gov ID: NCT05478876
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 80, women only
You may be able to join if
- Histological diagnosis
- Absence of skin extension
- N + (only if confined to the groin and pelvis)
- Age between 20-80 years
- ECOG 0-2
You likely can't join if
- Hip prosthesis, or metal prostheses or any other condition that prevents adequate imaging to identify the target volume and calculate the dose in the...
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Pavia, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pavia, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.