Mesothelioma and Radical Surgery Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 670
- 试验地点
- 34
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. 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. It is not yet known whether combination chemotherapy is more effective with or without surgery and radiation therapy in treating mesothelioma.
PURPOSE: This randomized clinical trial is studying combination chemotherapy, surgery, and radiation therapy to see how well they work compared to combination chemotherapy alone in treating patients with mesothelioma that can be removed by surgery.
详细描述
OBJECTIVES:
- Compare the feasibility of neoadjuvant combination chemotherapy with vs without surgery and adjuvant radiotherapy in patients with resectable malignant mesothelioma.
- Compare the overall survival of patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a multicenter, pilot study followed by a randomized, controlled study.
Patients undergo 3 courses of a platinum-based (cisplatin or carboplatin) combination chemotherapy regimen to be determined by the treatment center. Upon completion of combination chemotherapy, patients are randomized to 1 of 2 treatment arms provided tumor is resectable and there is no disease progression.
- Arm I: Patients undergo extra-pleural pneumonectomy followed by post-operative radiotherapy.
- Arm II: Patients undergo follow-up only. Patients may receive additional standard therapy according to their treatment center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically and immuno-histochemically confirmed malignant mesothelioma
- •Resectable disease (T1-3, N0-1, M0) with no distant metastases
- •Eligible to undergo extra-pleural pneumonectomy based on British Thoracic Society guidelines
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Normal renal function
- •Cardiovascular
- •Ejection fraction ≥ 40%
- •Predicted post-operative FEV_1 ≥ 40%
- •Predicted post-operative DLCO ≥ 40%
- •No significant pulmonary hypertension
- •No physical or personal condition that would preclude ability to undergo chemotherapy or post-operative radiotherapy
- •No physical or personal condition that would preclude ability to comply with follow-up requirements
- •PRIOR CONCURRENT THERAPY:
- •Not specified
排除标准
- 未提供