A Prospective Randomised Trial Comparing Temozolomide With PCV In The Treatment Of Recurrent WHO Astrocytic Tumours Grades III And IV
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of chemotherapy is more effective in treating recurrent malignant glioma.
PURPOSE: Randomized phase III trial to compare the effectiveness of temozolomide alone to that of procarbazine, lomustine, and vincristine in treating patients who have recurrent malignant glioma.
详细描述
OBJECTIVES:
- Compare the efficacy of temozolomide vs procarbazine, lomustine, and vincristine, in terms of overall survival, in patients with recurrent malignant glioma.
- Compare progression-free survival of patients treated with these regimens.
- Compare progression-free survival at 12 weeks in patients treated with two different schedules of temozolomide.
- Compare the overall survival of patients treated with two different schedules of temozolomide.
- Compare toxic effects of two different schedules of temozolomide in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
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Arm I:Patients are randomized to 1 of 2 treatment schedules:
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Schedule 1: Patients receive oral temozolomide once daily on days 1-5.
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Schedule 2:Patients receive oral temozolomide once daily on days 1-21. Treatment on both schedules repeats every 4 weeks for a maximum of 9 courses in the absence of disease progression or unacceptable toxicity.
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Arm II:Patients receive oral lomustine and vincristine IV on day 1 and oral procarbazine on days 1-21. Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed anaplastic astrocytoma, glioblastoma multiforme, or gliosarcoma
- •WHO grade III or IV at diagnosis or relapse
- •Must have undergone primary therapy including radiotherapy
- •Must be in first recurrence confirmed by CT scan or MRI
- •Evaluable disease by CT scan or MRI
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 1 month
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Total and direct bilirubin less than 1.5 times upper limit of normal (ULN)
- •SGOT or SGPT less than 3 times ULN
- •Alkaline phosphatase less than 2 times ULN
- •BUN less than 1.5 times ULN
- •Creatinine less than 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other concurrent serious illness
- •Considered fit to receive chemotherapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy for glioma
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •At least 2 months since prior radiotherapy
- •No prior radiosurgery, interstitial radiotherapy, or brachytherapy for glioma
- •Prior debulking surgery for recurrent disease allowed
排除标准
- 未提供
结局指标
主要结局
Overall survival
次要结局
- Toxicity
- Overall survival
- Quality of life as measured by EORTC QLQ-C30 and BTM
- Progression-free survival at 12 weeks (Arm II)
- Cost effectiveness