Postoperative Oncological Care for Patients With Meningioma With Malignant Components
试验速览
- 阶段
- 不适用
- 入组人数
- 1,204
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
Meningiomas with malignant components include grade II meningiomas (GIIM, the most common ones) and grade III meningiomas (GIIIM). They represent 5-35% of all meningiomas. Histological diagnosis of GIIM criteria were changed in 2007 and might be viewed by some as being quite subjective. "Standards of care" and consensus do not exist for GIIM, particularly in regards to performing, or not, radiotherapy after surgery. One other limitation in the literature is lack of data on health-related quality of life (HRQoL). Clinical trials for GIIM are very difficult to conduct. No results have been made available. Here, we propose to study clinical, pathological, radiological and therapeutic factors of an exhaustive population of GIIM and GIIIM patients, at national level. The main objective (for GIIM) is to assess the impact of postoperative radiotherapy, or the absence of postoperative radiotherapy, on overall survival and on quality of life
详细描述
Meningiomas with malignant components include grade II meningiomas (GIIM, the most common ones) and grade III meningiomas (GIIIM). They represent 5-35% of all meningiomas. Histological diagnosis of GIIM criteria were changed in 2007 and might be viewed by some as being quite subjective. "Standards of care" and consensus do not exist for GIIM, particularly in regards to performing, or not, radiotherapy after surgery. One other limitation in the literature is lack of data on health-related quality of life (HRQoL). Clinical trials for GIIM are very difficult to conduct. No results have been made available.
Main objective: to assess the impact of postoperative radiotherapy after GIIM surgery on overall survival (OS) in a population-setting study.
Secondary objectives (for GIIM and GIIIM):
- Evaluate the recurrence/progression free survival (PFS), volumetric velocity of the tumor growth (VVTG) after surgery and other treatment.
- Evaluate long term HRQoL.
- Evaluate the relevance and impact of histopathological review in a population setting.
- Looking for prognostic (clinical, radiological and biological) factors.
- Proposing therapeutic decision trees in general or for certain categories of patients.
- Identifying relevant cases to conduct further studies to identify new therapeutic targets.
- Perspectives for the TUCERA network to help design specific prospective projects.
- Looking for disparities in care management, survival and HRQoL in the various regions of France.
Design of the study: nationwide population-based study analysis and patterns of care/quality of care study, for all cases of incident GIIM and GIIIM operated in Metropolitan France during the 2007-2010 period.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
overall survival
时间窗: up to 10 years, since diagnosis
Description: Assessing the impact of postoperative radiotherapy after surgery on overall survival (OS) in population-based study of GIIM patients. Overall survival, the primary endpoint of this study, is defined as the time from surgery (histological diagnosis) to the time of death from any cause. Alive Patients at the time of the final analysis or who became lost to follow-up will be censored at their last date of giving news
次要结局
- Progression/Recurrence Free Survival, will be measured by month(up to 10 years, since diagnosis)
- the tumor growth(up to 10 years, since diagnosis)