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

Gynecologic Cancer Clinical Trial

— CYCLE  

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"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05478876
• Other study ID #: CNAO 40-2020 C CYCLE
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2020
• Est. completion date: September 2025

Study information

• Verified date: July 2022
• Source: CNAO National Center of Oncological Hadrontherapy
• Contact: Amelia Barcellini, MD
• Phone: 0039 0382078501
• Email: amelia.barcellini[@]cnao.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: September 2025
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer
• Malignant Melanoma
• Melanoma

Intervention

Radiation:
• carbon ion radiation therapy CIRT
CIRT: The low-dose CTV (clinical target volume) will receive a total dose of 43 GyRBE in 10 fractions, 4 fractions per week. The high-dose CTV will receive a total dose of 68.8 GyRBE in 16 fractions, 4 fractions per week. The expected duration of treatment is 4 weeks, 4 fractions per week. Treatments lasting longer than 6 weeks, or with less than 6 fractions administered on 14 consecutive days, will not be considered acceptable. Immunotherapy: Patients will undergo immunotherapy after carbon ion radiation therapy (CIRT) up to maximum response and/or up to tolerance. The concomitant association of immunotherapy is not envisaged in this protocol.

Locations

Country	Name	City	State
Italy	CNAO	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
CNAO National Center of Oncological Hadrontherapy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival	estimate 2-year PFS in patients diagnosed with mucosal melanoma of the lower genital tract, treated with carbon ion radiation therapy.	2 years
Secondary	Overall survival (OS)	The OS will be calculated from the end date of therapy with carbon ion radiation	3 years
Secondary	Toxicity according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0)	acute, medium term and late toxicity	within 3 months, 3-6 months, over 6 months from CIRT
Secondary	local response	according to Response Evaluation Criteria in Solid Tumours RECIST 1.1	3 years
Secondary	assessment of quality of life	assessed through questionarie Portec 3 administered on each follow up	3 years
Secondary	assessment of quality of life for >= 75 years old patients	assessed through questionnaire G8 Geriatric questionnaire administered on each follow up	3 years