Clinical trial NCT05478876: Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract
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"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Melanoma
Gynecologic Cancer
Keywords: hadrontherapy, gynecological melanoma
Lead sponsor: CNAO National Center of Oncological Hadrontherapy
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 9
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: cohort of 9 patients with primary gynecological melanoma. The intervention consists in carbon ion radiation therapy.

The expected duration of treatment is 4 weeks, 4 fractions per week.
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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

Primary outcomes:
measure: progression free survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 3 years
measure: Toxicity according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0)
timeFrame: within 3 months, 3-6 months, over 6 months from CIRT
measure: local response
timeFrame: 3 years
measure: assessment of quality of life
timeFrame: 3 years
measure: assessment of quality of life for >= 75 years old patients
timeFrame: 3 years
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: CNAO
Study officials:
affiliation: CNAO National Center of Oncological Hadrontherapy
name: Amelia Barcellini, MD
role: PRINCIPAL_INVESTIGATOR
References: