Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 751
- 试验地点
- 132
- 主要终点
- Overall Survival as Measured From the Day of Randomization
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma.
PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma.
详细描述
OBJECTIVES:
Primary
- To assess whether concurrent radiotherapy with daily temozolomide improves overall survival as compared to no daily temozolomide in patients with non-1p/19q deleted anaplastic glioma.
- To assess whether adjuvant temozolomide improves survival as compared to no adjuvant temozolomide in patients with non-1p/19q deleted anaplastic glioma.
Secondary
- To assess whether concurrent and adjuvant temozolomide prolongs progression-free survival and neurological deterioration-free survival in patients with non-1p/19q deleted anaplastic glioma.
- To assess the safety of concurrent and adjuvant temozolomide in patients with non-1p/19q deleted anaplastic glioma, including late effects on cognition.
- To assess the impact of concurrent and adjuvant temozolomide on the quality of life of patients with non-1p/19q deleted anaplastic glioma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（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
RT & Concurrent CT
Radiotherapy and concurrent temozolomide chemotherapy
干预措施: laboratory biomarker analysis (Other)
RT & Concurrent CT
Radiotherapy and concurrent temozolomide chemotherapy
干预措施: DNA methylation analysis (Genetic)
Radiotherapy (RT) alone
radiation therapy alone
干预措施: DNA methylation analysis (Genetic)
Radiotherapy (RT) alone
radiation therapy alone
干预措施: laboratory biomarker analysis (Other)
Radiotherapy (RT) alone
radiation therapy alone
干预措施: quality-of-life assessment (Procedure)
Radiotherapy (RT) alone
radiation therapy alone
干预措施: radiation therapy (Radiation)
RT & Concurrent CT
Radiotherapy and concurrent temozolomide chemotherapy
干预措施: temozolomide (Drug)
RT & Concurrent CT
Radiotherapy and concurrent temozolomide chemotherapy
干预措施: quality-of-life assessment (Procedure)
RT & Concurrent CT
Radiotherapy and concurrent temozolomide chemotherapy
干预措施: radiation therapy (Radiation)
RT + Adjuvant CT
Radiotherapy plus adjuvant temozolomide chemotherapy
干预措施: temozolomide (Drug)
RT + Adjuvant CT
Radiotherapy plus adjuvant temozolomide chemotherapy
干预措施: DNA methylation analysis (Genetic)
RT & Concurrent CT + adjuvant CT
Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy
干预措施: adjuvant therapy (Procedure)
RT + Adjuvant CT
Radiotherapy plus adjuvant temozolomide chemotherapy
干预措施: laboratory biomarker analysis (Other)
RT + Adjuvant CT
Radiotherapy plus adjuvant temozolomide chemotherapy
干预措施: adjuvant therapy (Procedure)
RT + Adjuvant CT
Radiotherapy plus adjuvant temozolomide chemotherapy
干预措施: quality-of-life assessment (Procedure)
RT + Adjuvant CT
Radiotherapy plus adjuvant temozolomide chemotherapy
干预措施: radiation therapy (Radiation)
RT & Concurrent CT + adjuvant CT
Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy
干预措施: temozolomide (Drug)
RT & Concurrent CT + adjuvant CT
Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy
干预措施: DNA methylation analysis (Genetic)
RT & Concurrent CT + adjuvant CT
Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy
干预措施: laboratory biomarker analysis (Other)
RT & Concurrent CT + adjuvant CT
Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy
干预措施: quality-of-life assessment (Procedure)
RT & Concurrent CT + adjuvant CT
Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Overall Survival as Measured From the Day of Randomization
时间窗: from date from enrollment till the date of death (time till death is up to 10.9 years after patient enrollment in the study)
The duration of survival is the time interval between randomization and the date of death due to any cause. Patients not reported dead or lost to follow up will be censored at the date of the last follow up examination.
次要结局
- Progression-free Survival(from randomization till the date of disease progression or death (time till death is up to 10.9 years after patient enrollment in the study))
- Neurological Deterioration Free Survival(within 2 weeks of randomization; during radiotherapy at week 4 and 6; 4 weeks after the end of radiotherapy; Six monthly after the end of radiotherapy; Prior to each cycle of adjuvant therapy; Every six months after the documentation of first progression.)
- Quality of Life of the Patient(from 14 days prior to randomization till five years or death (time till death is up to 10.9 years after patient enrollment in the study))