Phase II Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- complete response
研究概览
简要总结
The study aims to obtain a local control rate in patients with lateral pelvic relapses of gynecologycal cancers previously irradiated. High LET (Linear Energy Transfer) particles as carbon ions can guarantee a biologic advantage compared to photons in radioresistant neoplasms, given to their higher biological efficacy (RBE).
详细描述
Primary aim: estimate the effect, in terms of clinical response, of carbon ion treatment (CIRT) in patients with lateral pelvic recurrences of gynecological malignancies.
Secondary aims:
- To describe the safety profile of carbon ion therapy.
- To estimate the effect, in terms of survival, of carbon ion treatment
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years of age
- •Karnofsky Index ≥ 70
- •Histological or radiological diagnosis of pelvic and groin recurrence
- •Contraindications for radical surgery
- •No other distant progression or stable disease (SD) of known secondarisms (≥6 months)
- •Previous radiation therapy on pelvis
- •Distance ≥ 10mm between tumour and close intestinal tract (small intestine), radiologically evaluated
- •Possibility to perform a surgery to space the intestinal loops, in case of distance < 10mm
- •If needed, spacer in biocompatible material (silicon, goretex) or anatomical material (omentum, muscle patch), non-absorbable.
- •DICOM (Digital Imaging and COmmunications in Medicine) images of the previous treatment plan availability
- •Written informed consent
- •Patient's ability to understand the characteristics and consequences of the clinical trial
排除标准
- •Hip prosthesis, metal prostheses or any other condition that prevents adequate imaging to identify the target volume and calculate the dose in the treatment plan
- •Intestinal infiltration
- •Bladder infiltration
- •Vessel infiltration
- •Previous therapy with anti-angiogenesis drugs
- •Psychic or other disorders that may prevent informed consent
- •Previous invasive tumor, with the exception of skin cancer (excluding melanoma) unless disease-free for at least 3 years
- •Spacer in absorbable material (i.e. vycril)
- •Distance < 10mm between tumour and close intestinal tract (small intestine), radiologically evaluated
- •Impossibility to assess MRI
结局指标
主要结局
complete response
时间窗: 1 year after treatment
complete regression of the tumor lesion
partial response
时间窗: 1 year after treatment
Reduction of the tumor volume \> 65% of the initial volume
progression disease
时间窗: 1 year after treatment
Volume increase \> 73% of the initial volume.
local control
时间窗: 1 year after treatment
absence of progression disease, in patients with lateral pelvic recurrences of gynecological malignancies
stable disease
时间窗: 1 year after treatment
Volume between PR and PD
次要结局
- overall survival(1 year after treatment)
- Progression free survival(1 year after treatment)
- Toxicity assessment according to CTCAE v. 5(1 year after treatment)