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

NCT ID: NCT05478876

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-03
• Study Completion Date: 2027-09-30

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.

Conditions

Malignant Melanoma; Gynecologic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

carbon ion radiotherapy

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.

Group Type: EXPERIMENTAL

carbon ion radiation therapy CIRT

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

Other Intervention Names

immunotherapy

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CNAO National Center of Oncological Hadrontherapy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amelia Barcellini, MD

Role: PRINCIPAL_INVESTIGATOR

CNAO National Center of Oncological Hadrontherapy

Locations

CNAO

Pavia, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Amelia Barcellini, MD

Role: CONTACT

amelia.barcellini@cnao.it

0039 0382078501

Cristina Bono, MSc

Role: CONTACT

cristina.bono@cnao.it

0382078613

Facility Contacts

Cristina Bono, MSc

Role: primary

cristina.bono@cnao.it

0382078613

Other Identifiers

CNAO 40-2020 C CYCLE

Identifier Type: -

Identifier Source: org_study_id