Switch-Maintenance Gemcitabine After First-Line Chemotherapy (Pemetrexed-Platinum) In Patients With Malignant Pleural Mesothelioma In Ain Shams University Hospitals
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
Mesothelioma is an aggressive form of cancer. Treatments are available, but for many people, a cure isn't possible.
This thesis is to assess the efficacy and safety of switch-maintenance Gemcitabine in Mesothelioma patients after first line chemotherapy (Pemetrexed-Platinum)
详细描述
Malignant pleural mesothelioma is a rare but aggressive cancer of the pleural lining.
Malignant pleural mesothelioma accounted for 30,870 new cancer cases and 26,278 deaths worldwide in 2020.
In Egypt, Malignant pleural mesothelioma accounted for 337 new cases and 307 deaths in 2020.
Long-term exposure to asbestos is a well-established risk factor for Malignant pleural mesothelioma. It accounts for almost 80% of cases.
Malignant pleural mesothelioma is classified into three histologic subtypes: epithelioid, sarcomatoid, and biphasic. Epithelioid histology confers the most favorable prognosis and sarcomatoid the least.
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
- •Being at least 18 years old
- •Histologically or cytologically confirmed unresectable malignant pleural mesothelioma
- •ECOG Performance status 0-2
- •Completed at least four cycles of first line platinum (cisplatin or carboplatin) and pemetrexed combination chemotherapy before study entry
- •No evidence of disease progression following first-line treatment based on radiological criteria.
- •Adequate organ function is mandatory, defined as haemoglobin of at least 8.5 mg/dl, platelets of at least 100×10⁹ per L, and neutrophils of at least 1×10⁹/L.
排除标准
- •Progression of disease after first line
- •Pregnant females
- •ECOG Performance 3-4
- •Patients with sarcomatoid mesothelioma
- •Patients who are candidates for curative surgery
研究组 & 干预措施
Gemcitabine + supportive care
Administration of maintenance gemcitabine (1000 mg/m²) on days 1 and day 8, in cycles of 21 days plus supportive care.
干预措施: Gemcitabine (Drug)
Gemcitabine + supportive care
Administration of maintenance gemcitabine (1000 mg/m²) on days 1 and day 8, in cycles of 21 days plus supportive care.
干预措施: supportive care (Other)
supportive care
best supportive care alone.
干预措施: supportive care (Other)
结局指标
主要结局
progression free survival
时间窗: 2 years
It is the time from randomization to disease progression or death from any cause
次要结局
- overall survival(2 years)
- Toxicity of chemotherapy(2 years)