Phase 3 Superiority Trial Evaluating the Benefit of Dematerialized Information Media for Patients With Advanced Sarcomas Receiving Systemic Treatment for Metastatic or Locally Advanced Disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 377
- 试验地点
- 11
- 主要终点
- Severe toxicity in the first 3 months of treatment
研究概览
简要总结
ePPS-2202 is a study designed to evaluate the benefits of a dematerialised personalised care plan (PCP) compared to standard information/PCP for patients with advanced sarcomas receiving systemic treatment.
Participants will be randomised to an experimental group or a control group. Patients in the experimental group will receive the dematerialised PCP in addition to the standard PCP while patients in the control group will receive the standard PCP alone.
All patients will be followed until the end of second-line treatment, the start of a new line of treatment, or until the 24-month follow-up.
详细描述
ePPS-2202 is a phase 3, randomised,open-label, controlled, multicentre interventional study, designed to evaluate the benefits of a dematerialised personalised care plan (PCP) compared to standard information/PCP in patients with metastatic of locally advanced sarcomas with indication of a systemic treatment with pazopanib, tracbectedine, eribuline, ifosfamide or dacarbazine monotherapy.
Participants will be randomised to the experimental arm or the control arm. Patients in the experimental arm will receive the dematerialised PCP in addition to the standard PCP while patients in the control arm will receive the standard PCP alone.
All patients will be followed until the end of second-line treatment, the start of a new line of treatment, or until the 24-month follow-up.
The main analysis will compare the proportion of patients in each arm who experience at least one severe adverse event during the first 3 months of second-line treatment. Adverse events will be considered severe if they are graded 3 or higher according to NCI-CTCAE v5.0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Sarcomas of soft tissues or viscera ;
- •Inoperable metastatic or locally advanced disease ;
- •Indication for systemic treatment with pazopanib, trabectedine, eribulin, ifosfamide or dacarbazine monotherapy ;
- •Patient covered by French social security ;
- •Written, signed, informed consent ;
排除标准
- •Prior inclusion in ePPS trial for a prior systemic treatment ;
- •Poor understanding of French ;
- •Difficulty accessing a computer ;
- •Pregnant or nursing woman ;
- •Person deprived of liberty or under guardianship ;
- •Impossibility of undergoing medical follow-up for geographical, social or psychological reasons.
研究组 & 干预措施
Control group : standard PCP
Patient will receive standard support PCP
Experimental group : demateralized PCP
Patient will receive standard support PCP and dematerialized PCP (ePCP)
干预措施: Dematerialized Personalized Care Plan (ePCP) (Other)
结局指标
主要结局
Severe toxicity in the first 3 months of treatment
时间窗: 3 months
Severe toxicity will be assessed through the reporting of adverse events (AE). Will be considered as an AE all indesirable medical event regardless of the cause, occurring between randomisation and the end of treatment + 30days or the start of a new systemic anti-cancer treatment or the 24-month follow-up. All AE grade ≥ 3 according to Common Terminology Criteria for Adverse Events v5.0 scale (NCI-CTCAE) will be considered severe.
次要结局
- Severe toxicity(24 months)
- Survival weighted by quality of life(24 months)
- AEs leading to hospitalization(24 months)
- Overall survival (OS)(24 months)
- Progression-free survival (PFS)(24 months)
- Nature of severe AEs(24 months)
- Quality of life assessed by EORTC QLQ-C30 questionnaire(3 months)