Phase III Trial Evaluating Maintenance Treatment Versus Observation in Elderly Patients Suffering From Primary Central Nervous System Lymphoma in Complete Remission After High Dose Methotrexate Based Chemotherapy in First Line
试验速览
- 阶段
- 3 期
- 入组人数
- 428
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
Hypothesis
Our hypothesis is that maintenance chemotherapy will prolong complete remission obtained after a standard induction chemotherapy with an acceptable toxicity in the elderly.
Rationale
- Treatment of the elderly is challenging, indeed age over 60 is associated both with a poor prognosis and a high risk of treatment induced neurotoxicity with devastating consequences on quality of life. Therefore it has become standard practice to treat elderly in first line with high-dose methotrexate (MTX) based polychemotherapy alone, avoiding whole brain radiotherapy (WBRT) or deferring it for recurrence.
- There is a clear need to improve disease control after induction chemotherapy. Since consolidation with WBRT or intensive chemotherapy with autologous stem cell rescue are either poorly effective and/or too toxic in the elderly population, maintenance chemotherapy is an interesting alternative approach. Several agents, such as high-dose MTX, temozolomide (TMZ), rituximab, with a reported activity in PCNSL and acceptable safety profile, as single agent or combined, are good candidates for maintenance
详细描述
Objectives
-
The primary objective is to evaluate the benefit estimated by the PFS associated with maintenance chemotherapy compared to observation in patients ≥ 60 years having achieved a complete response after a high-dose MTX based induction chemotherapy
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The secondary objectives are to assess:
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Overall survival
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Safety of maintenance chemotherapy
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Neurocognitive outcome
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Quality of life of the patients
Inclusion and exclusion criteria
At registration
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
- 60 Years 至 —（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
maintenance chemotherapy
Clinical examination and MRI will be performed every 3 months for 2 years and then every 6 months until tumor progression.
Neurocognitive tests will be performed at randomization and annually. Quality of life questionnaires at randomisation and every 3 months
干预措施: Rituximab, Methotrexate, Temozolomide (Drug)
结局指标
主要结局
progression free survival
时间窗: 6 years
次要结局
- overall survival(6 years)
- Toxicity graded according to the NCI-CTCAE(6 years)
- Cognitive functions evaluated by a standardized and validated test battery exploring 5 cognitive domains(6 years)
- Quality of life(6 years)