Gynecologic Cancer, Malignant Melanoma
Conditions
Keywords
hadrontherapy, gynecological melanoma
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.
Interventions
RADIATIONcarbon 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.
Sponsors
CNAO National Center of Oncological Hadrontherapy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 3 years | The OS will be calculated from the end date of therapy with carbon ion radiation |
| 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 |
| 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 |
Countries
Italy
Contacts
Primary ContactAmelia Barcellini, MD
Backup ContactCristina Bono, MSc
Outcome results
None listed