KRANIOPHARYNGEOM 2007 - Multicenter Prospective Study of Children and Adolescents With Craniopharyngioma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Quality of life
研究概览
简要总结
The present investigation is a prospective, multicenter study evaluating craniopharyngioma patients' prognoses following the various currently-practiced therapeutic strategies.Primary goals of the study are to establish quality standards and compare the various therapy strategies with respect to their effectiveness and impact on the quality of life of treated patients. A stratified randomization of two treatment arms will be conducted with respect to timing of postoperative irradiation for the subgroup of patients ≥5 years of age whose tumors are incompletely resected. The researchers will investigate whether an immediate, postoperative irradiation is superior to progression-contingent irradiation based on alterations to quality of life (PEDQOL) from the time randomization is initiated (3rd month post op) to 3 years after randomization. Progression-free survival and overall survival will be examined as closely-related subgoals.Postoperative data will be evaluated via a surveillance study for all complete resection patients as well as for those patients under 5 years of age regardless of their resection grade.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with craniopharyngioma for the first time
- •Age at diagnosis 18 years or less of age
- •Agreement from patient's parents or legal guardian as well as the patient
- •Criteria for inclusion in randomization study
- •Histological diagnosis of craniopharyngioma
- •Age at diagnosis 18 years or less of age
- •Age at primary surgery over 5 years of age
- •Incomplete primary resection
- •Reference radiological confirmation of an incomplete resection
- •Agreement from patient's parents or legal guardian as well as the patient
排除标准
- •Age at diagnosis over 18 years of age No QoL measurement for randomization (3 months after surgery).
结局指标
主要结局
Quality of life
时间窗: 3 years after diagnosis
•Randomized investigation of children (≥ 5 years of age) and adolescent QoL changes (main goal assessment) following incomplete craniopharyngioma resections at primary diagnosis per QoL endpoint scores (PEDQOL "physical functions" domain) measured from 3rd month after surgery for 3 years after randomization; and the progression-free and total survival rates (subgoal assessments) relative to how these rates relate to postoperative irradiation timing (immediate postsurgery irradiation versus wait-and-see approach + progression-contingent irradiation of residual tumor).
次要结局
- Rate of Progression or relapse(3 years after surgery)
研究者
Prof. Dr. med. Hermann Mueller
Professor MD
Klinikum Oldenburg gGmbH