Hemithoracic Volumetric Modulated Arc Radiotherapy as Part of Lung-Sparing Multimodality Therapy in Patients With Malignant Pleural Mesothelioma Phase II Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Acute Radiation Toxicity
研究概览
简要总结
Malignant Pleural Mesothelioma is an aggressive and refractory disease , the most aggressive treatment plan offered to these patients include trimodalitiy approach with chemotherapy as the mainstay of treatment . the rationale of post operative Radiotherapy is to sterilize the post operative volume to reduce local failure meanwhile minimizing toxicities in this trial we are going to assess the safety and efficacy of Radiotherapy in Mesothelioma patients poat Pleural decortication
详细描述
This study will include malignant Pleural Mesothelioma patients treated by trimodalitiy approach starting with neoadjuvant chemotherapy followed by surgery in the form of Pleural decortication then all patients will receive post operative hemithoracic radiation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Evidence of metastatic disease.
- •Underwent Pleural decortication.
- •Able to provide informed consent.
排除标准
- •Poor pulmonary function tests.
- •Recurrent or palliative cases.
- •Inability to attend full course of Radiotherapy or follow up visits.
结局指标
主要结局
Acute Radiation Toxicity
时间窗: weekly assessment during radiation course and monthly follow up for the first 6 months
Questionnaire based Follow up about acute Radiation toxicity according to RTOG including dysnea , cough , chest pain , dysnea on effort from grade 1-5
late radiation toxicity
时间窗: Bi-monthly fashion of minimum 6 months post radiation course
follow up of patients using both Questionnaire and performing pulmonary function tests and Echo , focusing on DLCO \& FEV1
次要结局
未报告次要终点
研究者
Esraa Gamal
Assistant Lecturer of Radiation Oncology
Cairo University