NCT04469699终止2 期
Controlled Clinical Trial to Evaluate the Safety and Efficacy of Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma
University Hospital Muenster4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年4月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
In this multicenter, randomized, non-blinded trial the efficacy and safety of stereotactical photodynamic therapy with 5-aminolevulinic acid will be investigated in 106 patients with recurrent glioblastoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age 18 - 75 years
- •Karnofsky Performance Score (KPS) of ≥60 %
- •Radiologically suspected diagnosis (according to RANO criteria) of the first recurrence of a glioblastoma located in the cerebral hemisphere including insular and diencephalon. Tumors in the brain stem are excluded. First MRI with signs of first recurrence (radiologic RANO criteria for disease progression) within 8 weeks prior to Informed Consent. Not necessarily identical to primary tumor location
- •Single or single progressive contrast-enhancing lesion on MRI, largest diameter not more than 2.5 cm
- •For female and male patients of reproductive potential: Willingness to apply highly effective contraception (Pearl index <1) during the entire study
排除标准
- •Multifocal disease > 2 locations
- •Patients with significant non-enhancing tumor portions
- •Previous treatment of recurrence
- •Other malignant disease except basalioma
- •Hypersensitivity against porphyrins or Gliolan® or Fluorethylenpropylen (FEP )
- •HIV infection, active Hepatitis B or C infection
- •Bone marrow reserve:
- •white blood cell (WBC) count <2000/μl,
- •platelets <100000/μl,
- •Liver function:
- •total bilirubin > 1.5 times above upper limit of normal range (ULN)
- •alanine transaminase (ALT) and aspartate transaminase (AST) > 3 times ULN
- •Renal function:
- •creatinine > 1.5 times ULN
- •Blood clotting:
- •Quick/INR or PTT out of acceptable limits
- •Conditions precluding MRI (e.g. pacemaker)
- •Past medical history of diseases with poor prognosis, e.g. severe coronary heart disease, heart failure (NYHA III/IV), severe poorly controlled diabetes, immune deficiency, residual deficits after stroke, severe mental retardation or other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
- •Any active infection (at the discretion of the investigator)
- •Any psychological, cognitive, familial, sociological or geographical condition that, in the investigator's opinion, compromises the patient's ability to understand the patient information, to give informed consent or to comply with the trial protocol
- •Previous antiangiogenic treatment
- •Participation in another interventional clinical trial during this trial or within 4 weeks before entry into this trial.
- •Pregnancy or breastfeeding
研究组 & 干预措施
Treatment arm
Experimental
Stereotactic biopsy followed by stereotactical photodynamic therapy
干预措施: Stereotactic biopsy followed by stereotactical photodynamic therapy with 5-aminolevulinic acid (Drug)
Control arm
Other
Stereotactic biopsy
干预措施: Stereotactic biopsy (Procedure)
结局指标
主要结局
Progression free survival (PFS)
时间窗: through study completion (at least 1.5 years and a maximum of 5 years) or until progression or death
Progression free survival (PFS) measured as time from the day of randomization until diagnosis of progressive disease as determined by MRI according to RANO criteria (Response Assessment in Neuro-Oncology Criteria) or death from any cause
次要结局
- 6-month PFS rate(for each patient up to 6 months after randomization or until progression has occurred)
- Overall survival (OS)(through study completion (at least 1.5 years and a maximum of 5 years) or until death)
- 12-month OS rate(for each patient up to 12 months after randomization or until death)
- If a PET (positron emission tomography) was performed less than 2 weeks apart from an MRI: Consistency of both procedures with regard to the region of interest (ROI)(Baseline, 26 - 48 hours after stereotactic procedure, 1 month after randomization and then every 2 months, 1.5 years after randomization or at disease progression and then every 3 months until end of entire study (up to 5 years) or progression)
- Change in KPS (Karnofsky Performance Score)(Baseline, 26 -48 hours after stereotactic procedure, upon discharge or 7 days after stereotactic procedure, 1 month after randomization and then every 2 months until 1.5 years after randomization or disease progression)
- Change in the EORTC QLQ-BN20 module (European Organisation for Research and Treatment of Cancer Quality of Life Brain Cancer Module) score during study participation(Baseline, at discharge or 7 days after intervention, 1 month after randomization and then every 2 months, 1.5 years after randomization or at disease progression and then every 3 months until end of entire study (up to 5 years) or progression)
- Progression free time(through study completion (at least 1.5 years and a maximum of 5 years) or until progression)
- Absolute changes from baseline in contrast medium volume uptake from the MRI performed 48 hours after randomization on, and during any MRI performed thereafter to monitor for disease progression(Baseline, 26 - 48 hours after stereotactic procedure, 1 month after randomization and then every 2 months, 1.5 years after randomization or at disease progression, and then every 3 months until end of entire study (up to 5 years) or progression)
- 48h response rate on MRI (Complete Remission, Partial Remission, Stable Disease) after treatment with iPDT (interstitial photodynamic therapy)(26 - 48 hours after stereotactic procedure in patients treated with interstitial photodynamic therapy (iPDT))
- Brain edema as assessed by MRI within 26 to 48 h after stereotactic surgery(26 to 48 hours after stereotactic intervention)
- Change in NIHSS (National Institutes of Health Stroke Scale)(Baseline, 26 -48 hours after stereotactic procedure, upon discharge or 7 days after stereotactic procedure, 1 month after randomization and then every 2 months until 1.5 years after randomization or disease progression)
- Change in MMSE (Mini-Mental State Examination)(Baseline, 26 -48 hours after stereotactic procedure, upon discharge or 7 days after stereotactic procedure, 1 month after randomization and then every 2 months until 1.5 years after randomization or disease progression)
- Frequency of Adverse Events(over the entire study period of each patient (at least 1.5 years and a maximum of 5 years))
- Change in the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire) score during study participation(Baseline, at discharge or 7 days after intervention, 1 month after randomization and then every 2 months, 1.5 years after randomization or at disease progression and then every 3 months until end of entire study (up to 5 years) or progression)
研究者
研究点 (4)
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