Trimodality Therapy for Malignant Pleural Mesothelioma: Radical Pleurectomy, Followed by Adjuvant Chemotherapy With Cisplatin/Pemetrexed and Radiotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To determine the overall 5-year survival rate.
研究概览
简要总结
The role of surgical resection in the management of Malignant Pleural Mesothelioma (MPM) is still controversial. The selection criterion to perform either Extrapleural Pneumonectomy (EPP) or Pleurectomy/Decortication (P/D) is dependent not only on the cardio-pulmonary status of the patient, tumor stage and intraoperative findings but also on surgeons' decision and philosophy. There are no established guidelines. Radical Pleurectomy (RP) competes against EPP as surgical therapy modality. Both surgical approaches are cytoreductive treatment options. The aim is to remove all gross disease and to achieve macroscopic complete resection.
Originally P/D was a palliative option for controlling pleural effusion. But lung-sparing surgery for MPM seems to be an alternative to patients unsuitable or unwilling to undergo EPP in a multimodality therapy concept. Most studies evaluating multimodality therapies for MPM are based on retrospective analyses and their interpretation is difficult because of inhomogeneous patient groups studied.
The aim of our study was to analyze the feasibility and results of RP as surgical therapy modality in a standardized trimodality therapy concept.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Histologically confirmed diagnosis of MPM (all subtypes)
- •Clinical T1-3, N0-2, M0 disease.
- •No prior treatment for MPM.
- •Adequate renal and liver function
- •Adequate cardio-pulmonary reserves
排除标准
- •Patients with unresectable disease
- •Patients with an active infection that require systemic treatments
- •Patients with a concurrent active malignancy.
- •Patients with serious medical illness.
结局指标
主要结局
To determine the overall 5-year survival rate.
时间窗: 5-years
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(3 months)
- Number of Participants with treatment related deaths as a Measure of Safety and Tolerability(3 months)
- Recurrence(5 years)
