NCT00227630已完成2 期
A Phase II Feasibility Trial of Induction Chemotherapy Followed by Extrapleural Pneumonectomy and Postoperative Radiotherapy in Patients With Malignant Pleural Mesothelioma
European Organisation for Research and Treatment of Cancer - EORTC8 个研究点 分布在 4 个国家目标入组 59 人开始时间: 2005年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 8
- 主要终点
- Feasibility in terms of 90-day progression-free survival
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. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and cisplatin followed by surgery and radiation therapy works in treating patients with malignant pleural mesothelioma.
详细描述
OBJECTIVES:
Primary
- Determine the feasibility of neoadjuvant chemotherapy comprising pemetrexed disodium and cisplatin followed by extrapleural pneumonectomy and high-dose postoperative 3D-conformal radiotherapy, in terms of 90-day progression-free survival, in patients with malignant pleural mesothelioma.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine progression-free survival and overall survival of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 69 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed malignant pleural mesothelioma
- •All subtypes allowed
- •T1-3, N0-1, M0 disease
- •No N2 or N3 involvement confirmed by mediastinoscopy within 21 days before study entry
- •No clinical invasion of mediastinal structures (e.g., heart, aorta, spine, esophagus)
- •No wide-spread chest wall invasion except focal chest wall lesions
- •No clinical or radiological evidence of shrinking hemithorax
- •No clinically significant third-space fluid (e.g., pleural effusions or ascites) that cannot be managed with thoracentesis or pleurodesis
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC > 3,500/mm^3
- •Absolute neutrophil count > 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •Hemoglobin ≥ 11 g/dL
- •AST and ALT < 1.5 times upper limit of normal (ULN)
- •Bilirubin < 1.5 times ULN
- •Alkaline phosphatase < 1.5 times ULN
- •Creatinine clearance ≥ 60 mL/min
- •Acceptable (predicted) post-radiotherapy renal function by semiquantitative isotope renography, with a relative contribution of the contralateral kidney of ≥ 40%
- •See Disease Characteristics
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- •Deemed to be fit enough to undergo study treatment
- •No preexisting sensory neurotoxicity > grade 1
- •No uncontrolled infection
- •No prior or concurrent melanoma, breast cancer, or hypernephroma
- •No other malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated basal cell skin cancer
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent immunotherapy
- •No concurrent routine use of colony-stimulating factors during neoadjuvant chemotherapy
- •Concurrent secondary prophylactic use allowed during neoadjuvant chemotherapy
- •No concurrent secondary prophylactic use of colony-stimulating factors during post-operative radiotherapy
- •Chemotherapy
- •No prior chemotherapy for mesothelioma
- •Endocrine therapy
- •No concurrent hormonal cancer therapy
- •Radiotherapy
- •No prior radiotherapy to the lower neck, thorax, or upper abdomen
- •See Disease Characteristics
- •No other concurrent anticancer therapy
- •No other concurrent experimental medications
- •No nonsteroidal anti-inflammatory drugs or salicylates for 2 days before, during, and 2 days after administration of neoadjuvant chemotherapy (5 days before and 2 days after for drugs with a long half-life [e.g., naproxen, piroxicam, diflunisal, or nabumetone])
排除标准
- 未提供
结局指标
主要结局
Feasibility in terms of 90-day progression-free survival
次要结局
- Overall survival
- Toxicity
- Progression-free survival
研究者
研究点 (8)
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