NCT00165516已完成2 期
A Phase II Feasibility Study of Extrapleural Pneumonectomy With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 4
- 主要终点
- To monitor tumor recurrence and patient survival, and compare those results to historic controls.
研究概览
简要总结
The purposes of this study are: to evaluate the effects (good and bad) that administering heated cisplatin into the chest and abdomen cavity following surgical resection has on malignant mesothelioma; to collect data on the toxicity of cisplatin given directly into the chest and abdomen, and the levels of the cisplatin in the body; to determine if this treatment method has the possibility of helping patients with pleural mesothelioma live longer; and to determine if this treatment method can help decrease the rate of local recurrence of mesothelioma.
详细描述
- Patients will undergo surgery called extrapleural pneumonectomy which involves removal of the lung, the lining of the lung, the covering of the heart, and the muscle that separates the chest and abdomen. At the conclusion of the resection, if the patient has less then 1 cm3 of residual gross disease in one or more areas, then the heated chemotherapy lavage will begin. If more than this volume of disease is present, then the patient will receive additional treatment off-study.
- The chemotherapy treatment consists of a one-hour lavage of the chest and abdomen cavity with heated cisplatin given in the operating room through the surgical incision. At the completion of the hour, sodium thiosulfate is given intravenously to reduce the potential side effects of cisplatin.
- During the surgery and for four hours following the completion of the cisplatin lavage, blood samples, urine samples, chest wall muscle samples, and samples of the chemotherapy solution will be done in order to measure the concentration of chemotherapy and the impact of cisplatin on the various cell samples.
- Patients will remain in the hospital until they have recovered from surgery (7-14 days). Following discharge from the hospital, patients will be seen 1-2 weeks post-operatively for blood tests. 6 weeks later additional blood tests and and echocardiogram will be performed. This echocardiogram will be repeated 6 months post-operatively to re-assess heart function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male of non-pregnant female 18 years of age or older
- •HIstopathologic confirmation of malignant pleural mesothelioma
- •Ejection fraction > 45%
- •Evidence of adequate renal and hepatic function
- •Grossly normal contralateral pulmonary function with a chest radiograph and chest CT scan that do not show acute infiltrates
- •FEV1 > or = to 2.0L on a preoperative pulmonary function test
- •Karnofsky performance status of 70% or greater
排除标准
- •Extended disease outside the ipsilateral hemithorax as determined by pre-operative radiographs or intraoperative findings
- •Positive extrapleural nodes as determined by mediastinoscopy
- •Positive LENIs
- •Gross disease present within the hemithorax after surgery
- •Evidence of distant metastases
- •Severe non-malignant co-morbid disease: uncontrolled angina, myocardial infarction in the past 6 months, renal insufficiency, liver disease, pulmonary hypertension
- •Presence of active concomitant malignancy
- •Patients with a psychiatric or addictive disorder which would preclude informed consent
- •Previous chemotherapy or radiation therapy to treat mesothelioma
- •Chemotherapy or radiation therapy administered within 3 years for another malignancy
结局指标
主要结局
To monitor tumor recurrence and patient survival, and compare those results to historic controls.
次要结局
- to evaluate the pharmacokinetics of cisplatin.(3 years)
- To document the morbidity and mortality of this treatment protocol in this patient population(3 years)
研究者
研究点 (4)
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