Maintenance Therapy With Trabectedin Versus Observation After First Line Treatment With Doxorubicin of Patients With Advanced or Metastatic Soft Tissue Sarcoma.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 14
- 主要终点
- progression-free survival
研究概览
简要总结
Maintenance therapy with trabectedin versus observation after first line treatment with doxorubicin of patients with advanced or metastatic soft tissue sarcoma.
This is a prospective, multicenter, randomized, open label Phase III trial investigating whether a maintenance treatment with trabectedin, as compared to the observational approach, can prolong progression-free survival in patients with advanced, inoperable and/or metastatic STS after response or stabilisation during first line treatment with doxorubicin.
详细描述
Progression free survival will be estimated by the Kaplan-Meier method. The median survival time and its associated 95% non-parametric CI will be provided. Rates at 3 month intervals will be estimated using the log-log transformation of the Kaplan-Meier estimates and the standard deviation of the Kaplan Meier estimate based on the Greenwood formula.
For the primary analysis, PFS from randomization will be compared between the two arms using the score test from a Cox proportional hazards model adjusted for histology (stratification factor). The corresponding estimate of the treatment effect (hazard ratio) and 95% CI will be provided.
Secondary analyses include:
- the primary comparison of PFS repeated using methods for interval-censored data to adjust for deviations from the planned imaging scheduled, if any.
- the above mentioned analyses performed for PFS measured from date of starting firstline doxorubicin treatment.
Overall survival and time to second progression (PFS2) measured from randomization and from starting firstline doxorubicin treatment will be estimated by the Kaplan-Meier method. The median times and their associated 95% non-parametric CI will be calculated. Rates at 3 month intervals will be estimated using the log-log transformation of the Kaplan-Meier estimates and the standard deviation of the Kaplan Meier estimate based on the Greenwood formula. They will be compared between the two arms using an adjusted Cox proportional hazards model; the corresponding estimates of the hazard ratio and 95% CI will be provided. The above mentioned PFS2 comparison will also be repeated using methods for interval-censored data.
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
- 18 Years 至 —（Adult, Older Adult）
- 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
研究组 & 干预措施
investigational treatment
Trabectedin 1.2 mg/m² through a central venous catheter as an IV infusion over 24 hours every 4 weeks until disease progression (RECIST 1.1) or unacceptable toxicity.
干预措施: Trabectedin (Drug)
结局指标
主要结局
progression-free survival
时间窗: until 3/4 years after randomization of the first patient
The primary end-point is progression-free survival defined from randomization according to RECIST 1.1.
次要结局
- Health related quality of life (QLQ-C30)(until 3/4 years after randomization of the first patient)
- Time to second progression (PFS2)(until 3/4 years after randomization of the first patient)
- Safety and tolerability (Common Toxicity Criteria CTCAE 4.0)(until 3/4 years after randomization of the first patient)
- Overall survival(until 3/4 years after randomization of the first patient)