Aggressive Multi-Modality Management of Malignant Pleural Mesothelioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Best Response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as methotrexate, vinorelbine, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin may also make tumor cells more sensitive to radiation therapy. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy with or without surgery and chemoradiotherapy works in treating patients with malignant pleural mesothelioma.
详细描述
OBJECTIVES:
Primary
- Assess the response to induction combination chemotherapy comprising methotrexate, vinorelbine ditartrate, and cisplatin in patients with previously untreated malignant pleural mesothelioma.
Secondary
- Assess the tolerability and toxicity of this regimen in these patients.
- Determine relapse-free and overall survival of patients treated with induction combination chemotherapy with or without surgery and hemithoracic radiation.
- Assess the impact of induction combination chemotherapy on operability and surgical success.
- Evaluate the impact of these treatment regimens on quality of life.
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
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Induction Combination Chemotherapy
Induction chemotherapy: Patients get MVP chemo. Treatment repeats every 28 days for 2 courses.
Patients w/ unresectable disease may get up to 2 add'l courses of induction chemo. Patients requiring palliative radiotherapy or have PD are removed from study. Patients w/ resectable disease or sarcomatoid histology & T1-3, N1-2 disease w/ a CR or PR to induction chemo go to surgery.
Surgery: Patients w/ extensive disease get palliative debulking pleurectomy and decortication & are taken off study. Other patients undergo a thoracotomy w/ extrapleural pneumonectomy & proceed to chemoradiotherapy.
Chemoradiotherapy: At 6-10 weeks post-op, patients get 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients receive cisplatin IV over 30-60 minutes days 1 & 22. Patients w/ responding disease proceed to adjuvant chemotherapy.
Adjuvant chemotherapy: Patients get 2 more courses of MVP chemotherapy
干预措施: Cisplatin (Drug)
Induction Combination Chemotherapy
Induction chemotherapy: Patients get MVP chemo. Treatment repeats every 28 days for 2 courses.
Patients w/ unresectable disease may get up to 2 add'l courses of induction chemo. Patients requiring palliative radiotherapy or have PD are removed from study. Patients w/ resectable disease or sarcomatoid histology & T1-3, N1-2 disease w/ a CR or PR to induction chemo go to surgery.
Surgery: Patients w/ extensive disease get palliative debulking pleurectomy and decortication & are taken off study. Other patients undergo a thoracotomy w/ extrapleural pneumonectomy & proceed to chemoradiotherapy.
Chemoradiotherapy: At 6-10 weeks post-op, patients get 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients receive cisplatin IV over 30-60 minutes days 1 & 22. Patients w/ responding disease proceed to adjuvant chemotherapy.
Adjuvant chemotherapy: Patients get 2 more courses of MVP chemotherapy
干预措施: Methotrexate (Drug)
Induction Combination Chemotherapy
Induction chemotherapy: Patients get MVP chemo. Treatment repeats every 28 days for 2 courses.
Patients w/ unresectable disease may get up to 2 add'l courses of induction chemo. Patients requiring palliative radiotherapy or have PD are removed from study. Patients w/ resectable disease or sarcomatoid histology & T1-3, N1-2 disease w/ a CR or PR to induction chemo go to surgery.
Surgery: Patients w/ extensive disease get palliative debulking pleurectomy and decortication & are taken off study. Other patients undergo a thoracotomy w/ extrapleural pneumonectomy & proceed to chemoradiotherapy.
Chemoradiotherapy: At 6-10 weeks post-op, patients get 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients receive cisplatin IV over 30-60 minutes days 1 & 22. Patients w/ responding disease proceed to adjuvant chemotherapy.
Adjuvant chemotherapy: Patients get 2 more courses of MVP chemotherapy
干预措施: Vinorelbine ditartrate (Drug)
Induction Combination Chemotherapy
Induction chemotherapy: Patients get MVP chemo. Treatment repeats every 28 days for 2 courses.
Patients w/ unresectable disease may get up to 2 add'l courses of induction chemo. Patients requiring palliative radiotherapy or have PD are removed from study. Patients w/ resectable disease or sarcomatoid histology & T1-3, N1-2 disease w/ a CR or PR to induction chemo go to surgery.
Surgery: Patients w/ extensive disease get palliative debulking pleurectomy and decortication & are taken off study. Other patients undergo a thoracotomy w/ extrapleural pneumonectomy & proceed to chemoradiotherapy.
Chemoradiotherapy: At 6-10 weeks post-op, patients get 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients receive cisplatin IV over 30-60 minutes days 1 & 22. Patients w/ responding disease proceed to adjuvant chemotherapy.
Adjuvant chemotherapy: Patients get 2 more courses of MVP chemotherapy
干预措施: Adjuvant therapy (Procedure)
Induction Combination Chemotherapy
Induction chemotherapy: Patients get MVP chemo. Treatment repeats every 28 days for 2 courses.
Patients w/ unresectable disease may get up to 2 add'l courses of induction chemo. Patients requiring palliative radiotherapy or have PD are removed from study. Patients w/ resectable disease or sarcomatoid histology & T1-3, N1-2 disease w/ a CR or PR to induction chemo go to surgery.
Surgery: Patients w/ extensive disease get palliative debulking pleurectomy and decortication & are taken off study. Other patients undergo a thoracotomy w/ extrapleural pneumonectomy & proceed to chemoradiotherapy.
Chemoradiotherapy: At 6-10 weeks post-op, patients get 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients receive cisplatin IV over 30-60 minutes days 1 & 22. Patients w/ responding disease proceed to adjuvant chemotherapy.
Adjuvant chemotherapy: Patients get 2 more courses of MVP chemotherapy
干预措施: Conventional surgery (Procedure)
Induction Combination Chemotherapy
Induction chemotherapy: Patients get MVP chemo. Treatment repeats every 28 days for 2 courses.
Patients w/ unresectable disease may get up to 2 add'l courses of induction chemo. Patients requiring palliative radiotherapy or have PD are removed from study. Patients w/ resectable disease or sarcomatoid histology & T1-3, N1-2 disease w/ a CR or PR to induction chemo go to surgery.
Surgery: Patients w/ extensive disease get palliative debulking pleurectomy and decortication & are taken off study. Other patients undergo a thoracotomy w/ extrapleural pneumonectomy & proceed to chemoradiotherapy.
Chemoradiotherapy: At 6-10 weeks post-op, patients get 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients receive cisplatin IV over 30-60 minutes days 1 & 22. Patients w/ responding disease proceed to adjuvant chemotherapy.
Adjuvant chemotherapy: Patients get 2 more courses of MVP chemotherapy
干预措施: Neoadjuvant Therapy (Procedure)
Induction Combination Chemotherapy
Induction chemotherapy: Patients get MVP chemo. Treatment repeats every 28 days for 2 courses.
Patients w/ unresectable disease may get up to 2 add'l courses of induction chemo. Patients requiring palliative radiotherapy or have PD are removed from study. Patients w/ resectable disease or sarcomatoid histology & T1-3, N1-2 disease w/ a CR or PR to induction chemo go to surgery.
Surgery: Patients w/ extensive disease get palliative debulking pleurectomy and decortication & are taken off study. Other patients undergo a thoracotomy w/ extrapleural pneumonectomy & proceed to chemoradiotherapy.
Chemoradiotherapy: At 6-10 weeks post-op, patients get 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients receive cisplatin IV over 30-60 minutes days 1 & 22. Patients w/ responding disease proceed to adjuvant chemotherapy.
Adjuvant chemotherapy: Patients get 2 more courses of MVP chemotherapy
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Induction Combination Chemotherapy
Induction chemotherapy: Patients get MVP chemo. Treatment repeats every 28 days for 2 courses.
Patients w/ unresectable disease may get up to 2 add'l courses of induction chemo. Patients requiring palliative radiotherapy or have PD are removed from study. Patients w/ resectable disease or sarcomatoid histology & T1-3, N1-2 disease w/ a CR or PR to induction chemo go to surgery.
Surgery: Patients w/ extensive disease get palliative debulking pleurectomy and decortication & are taken off study. Other patients undergo a thoracotomy w/ extrapleural pneumonectomy & proceed to chemoradiotherapy.
Chemoradiotherapy: At 6-10 weeks post-op, patients get 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients receive cisplatin IV over 30-60 minutes days 1 & 22. Patients w/ responding disease proceed to adjuvant chemotherapy.
Adjuvant chemotherapy: Patients get 2 more courses of MVP chemotherapy
干预措施: Intensity-modulated radiation therapy (Radiation)
结局指标
主要结局
Best Response
时间窗: After 2-4 cycles of induction chemotherapy (28 day cycle)
Best response to chemotherapy after induction
次要结局
- Tolerability and toxicity(After 2-4 cycles of induction chemotherapy (28 day cycle))
- Relapse free and overall survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first)
- Assess Patient Quality of Life(Prior to initiation of each cycle of therapy, and every 3 months after completion of therapy until death, withdrawal or loss to follow up (Average 10 years))