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

Not Applicable

Recruiting

• Conditions: Gynecologic Cancer; Malignant Melanoma
• Interventions: Radiation: carbon ion radiation therapy CIRT

• Registration Number: NCT05478876
• Lead Sponsor: CNAO National Center of Oncological Hadrontherapy

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.

Study Timeline

• Study Start: 2020-09-03
• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2022-07-27
• Study First Posted: 2022-07-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 9

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
carbon ion radiotherapy	carbon ion radiation therapy CIRT	Patients affected by pelvic recurrence of gynecological cancer, who had not undergone to previous pelvic irradiation, will be enrolled on this study. After enrollment, patients undergo baseline exams, simulation CT and MRI and then carbon ion radiation therapy treatment will be performed, according to trial indications.

Primary Outcome Measures

Name	Time	Method
progression free survival	2 years	estimate 2-year PFS in patients diagnosed with mucosal melanoma of the lower genital tract, treated with carbon ion radiation therapy.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	3 years	The OS will be calculated from the end date of therapy with carbon ion radiation
local response	3 years	according to Response Evaluation Criteria in Solid Tumours RECIST 1.1
assessment of quality of life	3 years	assessed through questionarie Portec 3 administered on each follow up
assessment of quality of life for >= 75 years old patients	3 years	assessed through questionnaire G8 Geriatric questionnaire administered on each follow up
Toxicity according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0)	within 3 months, 3-6 months, over 6 months from CIRT	acute, medium term and late toxicity

Trial Locations

Locations (1)

CNAO; 🇮🇹 Pavia, Italy