NCT01650077已完成不适用
Early Assessment of Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria: Retrospective Study of Feasibility
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 6
- 主要终点
- To assess the feasibility of tumor response according to CHOI criteria
研究概览
简要总结
Non-interventional study consisting of a population of patients who had received for soft tissue sarcoma by at least 2 courses of Yondelis® at a dose of 1.5 mg / m² / 3 weeks after failure or intolerance to doxorubicin / ifosfamide from 2007 to 2011.
详细描述
Patient selection is based on a database of retrospectively within the GSF / GETO.
The tumor assessment must be made by scanner at baseline and post-C2 or C3 and should be available and sent to sponsor.
The comparative reading of the imaging is centralized and made without the knowledge of the local assessment:
- sum of the large diameter for 2 imagery (baseline and 1st evaluation
- tumor density on areas of interest for the 2 imaging (baseline and 1st evaluation
- Rank patients according to two methods (Choi and RECIST): complete response, partial response, stability, progress and non-assessable.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years
- •locally advanced or metastatic soft tissue sarcoma
- •treated with Yondelis after failure or intolerance to doxorubicin/ifosfamide
- •treated between 2007 and 2011
- •have had at least 2 cycles of Yondelis
- •assessment of tumor by CT scan (baseline and after 2 or 3 cycles of Yondelis)
排除标准
- •Gastro Intestinal Stromal Tumor GIST
- •primitive bone sarcoma
结局指标
主要结局
To assess the feasibility of tumor response according to CHOI criteria
时间窗: after 6 weeks of treatment
percentage of cases with a feasible evaluation according to CHOI
次要结局
- To classify patients into two categories (progression or no progression) according to RECIST and to CHOI(after 6 weeks of treatment)
- To determine percentage of false progression(after 6 weeks of treatment)
- To determine predictive values of progression free survival and overall survival(after 6 weeks of treatment)
- To characterize the profile of patients in false progression(after 6 weeks of treatment)
研究者
研究点 (6)
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