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

NCT05478876 | Recruiting

• 1 other identifier: CNAO 40-2020 C CYCLE
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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).

Conditions

Malignant Melanoma; Gynecologic Cancer

Keywords

hadrontherapy, gynecological melanoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall survival (OS)

  3 years

• Toxicity according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0)

  within 3 months, 3-6 months, over 6 months from CIRT

• local response

  3 years

• assessment of quality of life

  3 years

• assessment of quality of life for >= 75 years old patients

  3 years

Study Arms (1)

carbon ion radiotherapy

EXPERIMENTAL

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.

Radiation: carbon ion radiation therapy CIRT

Interventions

carbon ion radiation therapy CIRT 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.

Also known as: immunotherapy

carbon ion radiotherapy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Gender Eligibility Details: gynecological disease
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• CNAO National Center of Oncological Hadrontherapy: lead

Study Sites (1)

CNAO

Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Heavy Ion Radiotherapy; Immunotherapy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Immunomodulation; Biological Therapy

Study Officials

• Amelia Barcellini, MD

  CNAO National Center of Oncological Hadrontherapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amelia Barcellini, MD

CONTACT

0039 0382078501; amelia.barcellini@cnao.it

Cristina Bono, MSc

CONTACT

0382078613; cristina.bono@cnao.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: July 28, 2022
• Study Start: September 3, 2020
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

IT (1)