Efficacy of Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Local Relapse Free Survival
研究概览
简要总结
This is an observational mono-institutional study. Patients with gynecologic tumors treated with advanced radiotherapy- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT)- will be included and toxicity and outcomes analyzed.
详细描述
The patients with gynecological cancer treated with Advanced Radiotherapy (ART)- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT)- at the Department of Radiotherapy of "IRCCS San Raffaele Scientific Institute" (IRCCSSRaffaele) from January 2005 to January 2024 will be identified and their clinical and dosimetric data retrieved and analyzed.
The study objectives are the analysis of acute and late toxicity, and clinical outcomes, such as local, regional and distant control,disease free survival, cancer-specific survival, and overall survival. Secondary objective is the identification of prognostic factors for toxicity, disease progression, survival, including radiomic characteristics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •gynecologic cancer patients
- •>18 years old
- •treated with advanced radiotherapy techniques (IGRT, IMRT, SBRT)
排除标准
- •other tumors
- •> 90 years old
结局指标
主要结局
Local Relapse Free Survival
时间窗: From date of radiotherapy end until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
local control (on the treated site) of the disease
Distant Metastases Free Survival
时间窗: From date of radiotherapy end until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
distant metastases developed after the treatment
Disease Free Survival
时间窗: From date of radiotherapy end until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
absence of disease progression during the follow-up
Regional Relapse Free Survival
时间窗: From date of radiotherapy end until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
regional control (regional lymph nodal chain) of the disease
Overall Survival
时间窗: From date of radiotherapy end until the date of death from any cause, assessed up to 120 months
survival from all causes
Cancer Specific Survival
时间窗: From date of radiotherapy end until the date of death from disease progression, assessed up to 120 months
cancer survival
次要结局
- Late toxicity(From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months)
- Acute toxicity(Up to three months from the start of radiotherapy)