Long-term Survival of Advanced/Metastatic GIST Patients Responding to Imatinib Treatment: an Observational Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Patient characteristics
研究概览
简要总结
This is a cross-sectional cohort study of metastatic GastroIntestinal Stromal Tumor (GIST) patients on imatinib for ≥ 10 years included in EORTC trial 62005-STBSG entitled "Phase 3 randomized, intergroup, international tiral assessing the clinical activity of STI-571 at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) expressing the KIT receptor tyrosine kinase (CD117) - NCT00685828". With this study, the aim is to identify patient characteristics, tumour characteristics, treatment factors and quality of life outcomes associated with prolonged treatment with imatinib and/or prolonged survival. This observational study will further help to put in place a questionnaire to evaluate patients quality of life with prolonged imatinib treatment, that will then be used in a prospective study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 28 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients included in the EORTC 62005 trial: Adult patients with metastasized GIST
- •Patients who have been treated with imatinib for ten years or longer
- •For the identified patients who are still alive:
- •Able to read and answer questionnaires
- •Able to provide written informed consent
排除标准
- 未提供
结局指标
主要结局
Patient characteristics
时间窗: At time of registration
Age at time of randomization, gender, medical history and previous treatment(s)
Tumour characteristics
时间窗: At time of registration
Stage of the disease, tumor grade, tumor location and molecular features of primary tumor
Duration of imatinib treatment
时间窗: At time of registration
Time on imatinib treatment from start untill definitive discontinuation of imatinib treatment
Health releated quality of life
时间窗: At time of registration
QLQ-C30
Overall survival
时间窗: At time of registration
From time of randomization to the date of death, whatever the cause
次要结局
未报告次要终点