A Multicenter Randomized Phase III Trial on INTraoperative RAdiotherapy in Newly Diagnosed GliOblastoma Multiforme (INTRAGO II)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 314
- 试验地点
- 19
- 主要终点
- Median Progression-Free Survival
研究概览
简要总结
INTRAGO II resembles a multicentric, prospective, randomized, 2-arm, open-label clinical phase III trial which tests if the median progression-free survival (PFS) of patients with newly diagnosed glioblastoma multiforme (GBM) can be improved by the addition of intraoperative radiotherapy (IORT) to standard radiochemotherapy.
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 80 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
Experimental Arm (A)
Standard surgery plus intraoperative radiotherapy (20-30 Gy) followed by radiochemotherapy (EBRT: 60 Gy, 75 mg/m2/d temozolomide) and adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
干预措施: Standard surgery (Procedure)
Experimental Arm (A)
Standard surgery plus intraoperative radiotherapy (20-30 Gy) followed by radiochemotherapy (EBRT: 60 Gy, 75 mg/m2/d temozolomide) and adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
干预措施: Intraoperative radiotherapy (Radiation)
Experimental Arm (A)
Standard surgery plus intraoperative radiotherapy (20-30 Gy) followed by radiochemotherapy (EBRT: 60 Gy, 75 mg/m2/d temozolomide) and adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
干预措施: Radiochemotherapy (Radiation)
Experimental Arm (A)
Standard surgery plus intraoperative radiotherapy (20-30 Gy) followed by radiochemotherapy (EBRT: 60 Gy, 75 mg/m2/d temozolomide) and adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
干预措施: Temozolomide (Drug)
Control Arm (B)
Standard surgery followed by radiochemotherapy (EBRT: 60 Gy, 75 mg/m2/d temozolomide) and adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
干预措施: Standard surgery (Procedure)
Control Arm (B)
Standard surgery followed by radiochemotherapy (EBRT: 60 Gy, 75 mg/m2/d temozolomide) and adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
干预措施: Radiochemotherapy (Radiation)
Control Arm (B)
Standard surgery followed by radiochemotherapy (EBRT: 60 Gy, 75 mg/m2/d temozolomide) and adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
干预措施: Temozolomide (Drug)
结局指标
主要结局
Median Progression-Free Survival
时间窗: 24 Months
Determined according to modified Response Assessment in Neuro-Oncology (RANO) criteria and serial perfusion imaging
次要结局
- Median Overall Survival(24 Months)
- OS with respect to Age(24 Months)
- PFS within a 1-2 cm margin around the cavity(24 Months)
- PFS with respect to KPS(24 Months)
- OS with respect to thickness of anticipated T1-Gd-enhancing (remaining) tumor margin(24 Months)
- OS with respect to extent of resection(24 Months)
- Activities of daily living (ADL), assessed using the Barthel Index (Mahoney & Barthel, 1965).(24 Months)
- PFS with respect to Age(24 Months)
- OS with respect to KPS(24 Months)
- Quality of Life (QoL) questionnaire(24 Months)
- Radiation-related (acute / early delayed / late) neurotoxicity(24 Months)
- PFS with respect to thickness of anticipated T1-Gd-enhancing (remaining) tumor margin(24 Months)
- OS with respect to MGMT promoter methylation status(24 Months)
- PFS with respect to MGMT promoter methylation status(24 Months)
- PFS with respect to extent of resection(24 Months)
研究者
Frank A. Giordano
PI (Chair)
Heidelberg University