Carbon Ion Radiation Therapy for Treating Mucosal Melanoma of the Female Lower Genital Tract A Phase 2 Study Evaluating Progression-Free Survival and Local Control

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.

Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract