Radiochemotherapy Treatment Followed by Interventional Radiotherapy in Patients Affected by Vagina Carcinoma Multi-centric Prospective Observational Study Trimodal Definitive Invasive Vaginal Carcinoma Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- Local Control
研究概览
简要总结
Prospective observational multicenter study, aimed at evaluating the effectiveness on local control and cancer-specific survival of radiochemotherapy followed by interventional radiotherapy in patients affected by vaginal cancer
详细描述
Prospective observational multicenter study, aimed at evaluating the effectiveness on local control and cancer-specific survival of radiochemotherapy (45Gy on pelvis and tumor plus chemotherapy with cisplatinum) followed by interventional radiotherapy (28Gy on residual tumor) in patients affected by vaginal cancer
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age more than18 years old
- •Performance status 0,1
- •Hystological diagnosis of squamous vaginal cancer
- •HPV, p16, p53 status
- •Stage I, II, III and IV (AJCC 2018th version)
- •Stadiation with magnetic resonance and positron emission tomography
- •Informed consensus
排除标准
- •Age inferior 18 years old
- •Performance status more than 2
- •Previous cancer in the last ten years
- •Previous radiation treatment in the region of interest
- •Presence of pathologies that contraindicate radiotherapy treatment (genetic syndromes of hyper-radiosensitivity, ulcerative colitis, diverticulitis in the acute phase, severe diverticulosis, chronic pelvic inflammation)
- •Presence of internal pathologies that contraindicate chemotherapy or radio-chemotherapy treatment (severe liver disease, heart disease, renal failure, etc.)
- •Presence of distant metastases in sites other than the pelvic lymph nodes
- •Any significant medical condition that in the opinion of the investigator may interfere with the patient's optimal participation in the study
结局指标
主要结局
Local Control
时间窗: 6 months
Local control, the Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment
次要结局
- Toxicities(6 months)
- Overall survivall(6 months)
- Disease free survivall(6 months)
- Cancer specific overall survival(6 months)
- Metastasis free survival(6 months)
- Changes in quality of life over time(6 months)