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"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- progression free survival
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis
- •Absence of skin extension
- •N + (only if confined to the groin and pelvis)
- •Age between 20-80 years
- •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)
排除标准
- •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
结局指标
主要结局
progression free survival
时间窗: 2 years
estimate 2-year PFS in patients diagnosed with mucosal melanoma of the lower genital tract, treated with carbon ion radiation therapy.
次要结局
- Overall survival (OS)(3 years)
- local response(3 years)
- assessment of quality of life(3 years)
- assessment of quality of life for >= 75 years old patients(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)