NCT04810182已完成不适用
Regorafenib in Relapsed Glioblastoma. An Observational, Multicentric and Prospective Study. IOV-GB-1-2020 REGOMA-OSS
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 29
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study aims to analyze the role the of Regorafenib in prolonging the Overall Survival of glioblastoma multiforme patients who progressed after surgery and a first-line chemo-radiotherapy treatment in the setting of "real world life".
详细描述
The primary aim of the study
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years of age
- •Histologically confirmed glioblastoma (grade IV)
- •First recurrence after adjuvant treatment (surgery followed by radiotherapy and temozolomide chemotherapy) in patients who have not received further therapeutic interventions
- •World Health Organization (WHO) Performance status ≤ 1 (or Karnofsky performance status (KPS) ≥70)) before the start of the treatment
- •Documented progression of disease as defined by RANO criteria at least 12 weeks after completion of radiotherapy, unless the recurrence is outside the radiation field or has been histologically documented.
- •Documented progression of disease by a brain MRI scan done within 14 days before the start of treatment with Regorafenib.
- •Stable or decreasing dosage of steroids for 7 days prior to the baseline MRI scan.
- •Have adequate bone marrow function, liver function, and renal function, as measured by the following laboratory assessments conducted within 7 days prior to the initiation of study treatment:
- •Hemoglobin >9.0 g/dl
- •Absolute neutrophil count (ANC) >1500/mm3 without transfusions or granulocyte colony stimulating factor and other hematopoietic growth factors
- •Platelet count ≥100,000/μl
- •White blood cell count (WBC) >3.0 x 109/L
- •Total bilirubin <1.5 times the upper limit of normal
- •ALT and AST <3 x upper limit of normal
- •Serum creatinine <1.5 x upper limit of normal
- •Alkaline phosphatase <2.5 x ULN (<5 x upper limit of normal value)
- •PT-INR/PTT <1.5 x upper limit of normal
- •Lipase ≤ 1.5 x the ULN
- •Glomerular filtration rate ≥ 30 mL/min/1.73 m2
- •TSH, fT3,fT4 within normal limits
- •Patients may have undergone surgery for the recurrence; the histological report must document a glioblastoma recurrence. If operated:
- •at least 28 days from the surgery is required prior to Regorafenib administration and patients should have fully recovered.
排除标准
- •Have had prior treatment with regorafenib or any other VEGFR-targeting kinase inhibitor
- •Have had systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and/or hormonal therapy within 4 weeks prior to initiation of treatment
- •Recurrent disease located outside of the brain
- •Have uncontrolled hypertension (systolic blood pressure [SBP] > 140 mmHg or diastolic blood pressure [DBP] > 90 mmHg) despite optimal medical management
- •Have had a myocardial infarction < 6 months prior to initiation of treatment with Regorafenib
- •Have had arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within 6 months prior to the initiation of treatment with Regorafenib
- •Have either active or chronic hepatitis B or C requiring treatment with antiviral therapy
- •Are taking strong cytochrome P (CYP) CYP3A4 inhibitors (eg, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort)
研究组 & 干预措施
Glioblastoma Patients treated with Regorafenib
Patients with a confirmed diagnosis of Glioblastoma for whom a decision to treat with regorafenib has been made (by the treating physician).
干预措施: Regorafenib 40 MG Oral Tablet [STIVARGA] (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From the enrolment date to the date of death, for any cause, or to the last follow-up, assessed up to 18 months
Overall Survival is defined as the time from date of enrolment to the date of death due to any cause
次要结局
- Progression free survival (PFS)(From the date of enrolment to the date of disease progression or to the date of death, assessed up to 18 months)
- Toxicity (Graded according to the NCI-Common Terminology Criteria for Adverse Events-CTCAE v5.0)(From the start of Regorafenib treatment up to 30 days after the end of treatment)
- Disease control rate (DCR)(Approximately 24 months)
- Objective response rate (ORR)(Approximately 24 months)
研究者
研究点 (29)
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