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Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract
NCT05478876 · CNAO National Center of Oncological Hadrontherapy
In plain English
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Official title
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"
About this study
Patients with primary gynaecological melanoma, non-metastatic, non-suitable for surgery, and not previously subjected to conventional radiotherapy can be enrolled in the trial, according to selection criteria. After requested baseline exams, the patient undergoes to simulation phase for the carbon ion radiation therapy, according to study constraints. The patient will then receive immunotherapy not concomitant to CIRT. The response is evaluated through RECIST criteria.
PFS is the primary endpoint, calculated from the end of CIRT to date of disease progression or death or last follow up.
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
Study design
Enrollment target: 9 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2020-09-03
Estimated completion: 2027-09
Last updated: 2024-08-21
Interventions
Radiation: carbon ion radiation therapy CIRT
Primary outcomes
- • progression free survival (2 years)
Sponsor
CNAO National Center of Oncological Hadrontherapy · other
Contacts & investigators
ContactAmelia Barcellini, MD · contact · amelia.barcellini@cnao.it · 0039 0382078501
ContactCristina Bono, MSc · contact · cristina.bono@cnao.it · 0382078613
InvestigatorAmelia Barcellini, MD · principal_investigator, CNAO National Center of Oncological Hadrontherapy
All locations (1)
CNAORecruiting
Pavia, Italy