Multicenter Randomized Phase II Study of Methotrexate (MTX) and Temozolomide Versus MTX, Procarbazine, Vincristine and Cytarabine for Primary CNS Lymphoma (PCNSL) in the Elderly
试验速览
- 阶段
- 2 期
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The purpose of this study is to evaluate two types of chemotherapy for primary central nervous system lymphoma in the elderly (age older than 60) :
- Methotrexate, procarbazine, vincristine and cytarabine
- Methotrexate and temozolomide
详细描述
The aim of the study is to evaluate efficacy and toxicity associated with both protocols in this population, without radiotherapy.
Patients will be randomized to receive one of the two regimens in one of the participating centers. Neuropsychological evaluation will be performed in all patients. Patients will be followed with serial MRIs.
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
- •primary central nervous system lymphoma histologically confirmed by brain biopsy, CSF cytology or vitrectomy
- •KPS 40 or higher
- •Absence of systemic disease as evaluated by chest-abdomen-pelvis CT scan
- •Leucocytes>3.500/mm3, platelets>130.000/mm3, Bilirubin < 2 mg, transaminases < 2.5 N), creatinine < 150 μM/l, creatinine clearance > 40 ml/min
- •Age ≥ 60 years
- •Negative HIV test
- •Signature of informed consent
排除标准
- •previous cranial radiotherapy
- •prior chemotherapy for primary central nervous system lymphoma
- •presence of another cancer (excepting basal cell carcinoma of the skin and cervical carcinoma in situ )
- •systemic lymphoma (outside the CNS)
- •Isolated ocular lymphoma
- •Immunosuppressed patients (HIV , use of immunosuppressors)
- •Other uncontrolled or progressive disease compromising shot-term survival
- •Severe renal or hepatic disease
- •Patients not legally covered by the French Social Security
- •Inability to swallow the medication
研究组 & 干预措施
1
Comparative evaluation of the efficiency of a new protocol of the primitive LYMPHOME of the central nervous system ( LPSNC) to the old subject, associating Methotrexate and Temozolomide with regard to a standard protocol associating Methotrexate, Procarbazine, Vincristine and Cytarabine.
干预措施: Methotrexate and temozolomide (Drug)
bras conventional
bras conventional
干预措施: Methotrexate , procarbazine ,vincristine ,cytarabine (Drug)
结局指标
主要结局
Progression-free survival
时间窗: at one year
次要结局
- Overall survival:median and overall survival(at one and two years)
- Response rates(at end of treatment)
- Toxicity(during treatment)
- Late toxicity(2 to 5 years after treatment)