Actively Recruiting
Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract CNAO 40-2020 C CYCLE
Led by CNAO National Center of Oncological Hadrontherapy · Updated on 2024-08-21
9
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating carbon ion radiation therapy for treating mucosal melanomas of the female lower genital tract, focusing on patients with non-metastatic disease not suitable for surgery. This phase 2 study aims to reproduce promising progression-free survival and local control rates previously observed, while allowing immunotherapy before or after radiation. Carbon ions offer a potential advantage in targeting radio-resistant tumors with precise dosing that spares nearby healthy organs. Participants will receive carbon ion radiation therapy over about four weeks, with low-dose and high-dose clinical target volumes treated in 10 and 16 fractions respectively, four times per week. Immunotherapy is administered after radiation but not at the same time. Baseline exams, simulation CT and MRI scans are done before treatment to plan therapy and evaluate response using standard criteria. During the study, patients undergo regular assessments including imaging and clinical exams to monitor tumor progression, survival, toxicity, and quality of life for up to three years. The primary outcome is progression-free survival at two years. Safety and side effects are tracked using established criteria within six months after radiation. Quality of life is also evaluated, especially for patients aged 75 or older. The total participation duration spans several years to capture long-term results.
CONDITIONS
Brief Title
Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of mucosal melanoma
- No extension to the skin
- Lymph node involvement allowed only if confined to groin and pelvis
- Age between 20 and 80 years
- ECOG performance status 0 to 2
- No evidence of metastasis
- Tumor at least 5 mm away from rectum and bladder wall
- No previous radiotherapy
- Written informed consent provided
- Ability to understand trial details and consequences
- Molecular characterization/mutational status available
- Disease staging completed with baseline exams
You will not qualify if you...
- Presence of hip or metal prostheses that prevent adequate imaging for treatment planning
- Psychiatric or other disorders preventing informed consent
- Previous invasive tumor unless disease-free for at least 3 years
- Contraindications to MRI
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks
Participants undergo baseline exams and simulation CT and MRI to prepare for carbon ion radiation therapy.
1 to 2 visits
Duration - Carbon ion radiation therapy: about 4 weeks; Immunotherapy: variable duration after radiation therapy
Participants receive carbon ion radiation therapy over approximately 4 weeks, with 4 treatment fractions per week. After radiation therapy, participants receive immunotherapy until maximum response or tolerance.
4 visits per week during radiation therapy; additional visits for immunotherapy
Duration - Up to 3 years
Participants are monitored for disease progression, survival, toxicity, and quality of life for up to 3 years after treatment.
Periodic visits over 3 years
Trial Site Locations
Total: 1 location
1
CNAO
Pavia, Italy, 27100
Actively Recruiting
Research Team
A
Amelia Barcellini, MD
C
Cristina Bono, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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