Neoadjuvant Chemotherapy and Extrapleural Pneumonectomy of Malignant Pleural Mesothelioma (MPM) With or Without Hemithoracic Radiotherapy. A Randomized Multicenter Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 13
- 主要终点
- Complete macroscopic resection (part 1)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium together with cisplatin followed by surgery with or without radiation therapy works in treating patients with malignant pleural mesothelioma.
详细描述
OBJECTIVES:
Primary
- Evaluate the short-term outcomes and feasibility of neoadjuvant therapy with pemetrexed disodium and cisplatin followed by extrapleural pneumonectomy in patients with malignant pleural mesothelioma.
- Evaluate the long-term outcomes and feasibility of postoperative hemithoracic radiotherapy in patients with R0 or R1 resection.
Secondary
- Determine the quality of life of these patients.
- Identify predictive and prognostic markers in these patients.
- Determine relapse-free or progression-free survival and overall survival of these patients.
- Collect tissue and blood from these patients.
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 69 Years（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
Radiotherapy
干预措施: Pemetrexed (Drug)
No radiotherapy
干预措施: Cisplatin (Drug)
No radiotherapy
干预措施: Pemetrexed (Drug)
No radiotherapy
干预措施: Therapeutic conventional surgery (Procedure)
Radiotherapy
干预措施: Cisplatin (Drug)
Radiotherapy
干预措施: Therapeutic conventional surgery (Procedure)
Radiotherapy
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Complete macroscopic resection (part 1)
时间窗: After surgery (15 weeks after trial registration)
Loco-regional relapse-free survival (part 2)
时间窗: From surgery until the first occurrence of loco-regional relapse
次要结局
- Response to neoadjuvant therapy (part 1)(Every 6 months in the follow-up until death for a maximum of 5 years)
- Operability (part 1)(Proportion of patients remaining operable after completing chemotherapy (9 weeks after trial registration))
- Surgical complications (part 1)(Within 3 month after surgery)
- Relapse-free or progression-free survival (part 1)(From registration until progression/relapse (loco-regional or distant) or death)
- Adverse drug reaction to neoadjuvant therapy (part 1)(According to CTCAE)
- Adverse reaction to postoperative radiotherapy (part 2)(According to CTCAE)
- Late toxicity (part 2)(Late toxicities occurring later than 6 weeks after the last RT fraction)
- Psychological distress (quality of life) (part 2)(Until 22 weeks after treatment termination)
- Reasons for non-randomization (part 1)(Reasons for non-randomization include macroscopic incomplete resection, patients' refusal or patient can not be subjected to RT within 10 weeks after surgery.)
- Feasibility of postoperative radiotherapy (part 2)(Proportion of patients receiving at least 90% of planned RT dose)
- Relapse-free survival (part 2)(From registration until progression/relapse (loco-regional or distant) or death)
- Overall survival(From registration until death for all registered patients, and from randomization to death for all randomized patients.)