A Randomized Trial of Delayed Radiotherapy in Patients With Newly Diagnosed 1p/19q Codeleted Anaplastic Oligodendroglial Tumors: the POLCA Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 33
- 主要终点
- Survival without neurocognitive deterioration
研究概览
简要总结
Patients with 1p/19q-codeleted anaplastic gliomas treated with RT + PCV are at risk of neurocognitive deterioration. Treating these patients with PCV alone (could reduce the risk of neurocognitive deterioration without impairing overall survival.
详细描述
Multicentric, Randomized phase III study (1:1), Population: newly diagnosed 1p/19-codeleted anaplastic gliomas, Primary objective: To determine whether treating newly diagnosed 1p/19q-codeleted anaplastic gliomas with PCV alone can increase overall survival without neurocognitive deterioration Control group: radiotherapy followed by 6 cycles of PCV chemotherapy. Experimental group: 6 cycles of PCV chemotherapy (radiotherapy being deferred at the time of progression).
Number of centres participating: the 33 centers of the POLA network Recruitment duration: 7 years, the accrual rate being 40 patients per year, and patients are followed-up until the end of the trial.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of anaplastic glioma by central pathological review
- •Tumor is co-deleted for 1p and 19q
- •Age ≥ 18 years of age
- •Newly diagnosed and ≤3 months from surgical diagnosis
- •Willing and able to complete neurocognitive examination and the QOL
- •Karnofsky performance status ≥ 60
- •The following laboratory values obtained ≤ 21 days prior to registration:
- •Absolute neutrophil count (ANC) ≥1500 /mm3
- •Platelet count ≥100,000 / mm3
- •Hemoglobin > 9.0 g/dL
- •Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- •SGOT (AST) ≤ 3 x ULN
- •Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
- •Provide informed written consent
排除标准
- •Pregnant and nursing women
- •Men or women of childbearing potential who are unwilling to employ adequate contraception during this study and for up to 6 months following the completion of PCV.
- •Received any prior radiation therapy or chemotherapy for any CNS neoplasm.
研究组 & 干预措施
experimental
Administration of 6 cycles of PCV chemotherapy PCV chemotherapy is given as: Day 1: CCNU 110 mg/m2 orally; Days 8 and 29: vincristine 1.4 mg/m2 IV; Days 8 to 21: procarbazine 60 mg/m2 orally
干预措施: PCV chemotherapy alone (Drug)
control
radiotherapy followed by 6 cycles of PCV chemotherapy given as: Day 1: CCNU 110 mg/m2 orally; Days 8 and 29: vincristine 1.4 mg/m2 IV; Days 8 to 21: procarbazine 60 mg/m2 orally
干预措施: Radiotherapy+PCV chemotherapy (Drug)
结局指标
主要结局
Survival without neurocognitive deterioration
时间窗: 9 years
Survival without neurocognitive deterioration (whatever the cause of deterioration, i.e toxicity or tumor progression) defined as the time from study registration to failure in any of the 6 cognitive domains that will be explored (i.e memory, working memory, language, visuo-spatial ability, cognitive executive functions, behavioral executive functions) or death due to any cause, whichever occurs first.
次要结局
- progression free survival(9 years)
- overall survival(9 years)