The Use of TTFields for Newly Diagnosed GBM Patients in Germany in Routine Clinical Care - TIGER Study
试验速览
- 阶段
- 不适用
- 入组人数
- 710
- 试验地点
- 1
- 主要终点
- Number of TTFields treatment-related serious adverse events (SAEs) standardized to one year of FU time
研究概览
简要总结
The purpose of this post-authorisation medical device study is to obtain real life data on the use of tumor-treating fields (TTFields) in patients with newly diagnosed GBM in routine clinical care in Germany. Patients with newly diagnosed GBM and clinical indication for TTFields treatment will be enrolled in the study after signing Informed consent to use their data and process it centrally for research purposes. The clinical indication for TTFields is one of the inclusion criteria and is defined prior to inclusion by the treating physician. The patient's decision regarding TTFields treatment is part of the observation and will be assessed within the baseline visit.
详细描述
Glioblastoma (GBM) is the most common malignant primary tumor of the brain. The current standard of care for patients with newly diagnosed GBM consists of maximal surgical resection, approx. 60 Gy of radiotherapy together with chemotherapy using temozolomide (TMZ), followed by maintenance TMZ for 6 months. This treatment scheme was shown to extend median survival from 12.1 to 14.6 months compared to surgery and radiotherapy alone. This survival was essentially unchanged since 2005 despite numerous clinical Phase 3 trials conducted.
Although immense efforts were made over the years with different treatment strategies, the survival of patients with newly diagnosed GBM remained very poor until recently. Tumor-treating fields (TTFields) are low-intensity, intermediate frequency, alternating electric fields delivered continuously through adhesive patches, called transducer arrays, to the area of the brain where the GBM tumor is located and help slow down or stop glioblastoma cancer cells from dividing. These transducer arrays are applied to the scalp and are connected to the wearable and portable device.
TTFields are the first treatment since 2005 to demonstrate significantly extended median overall survival and significantly improved long-term survival (one to five year survival rates) compared to the current standard of care. In addition, TTFields significantly extended progression-free survival.
In the Phase 3 trial in newly diagnosed GBM (trial EF-14) the results demonstrated that the addition of TTFields to maintenance TMZ significantly extends both, median and long term survival, as well as progression free survival of patients with newly diagnosed GBM. The magnitude of survival benefit seen is even better to that seen for addition of TMZ to radiation, which established TMZ as the standard of care for 1st line GBM treatment in 2005. Quality of life (QoL) was maintained with the use of TTFields + TMZ in patients for whom 12 months of QoL data were available. The addition of TTFields to TMZ therapy in patients with newly diagnosed glioblastoma was not associated with any significant increase in systemic toxic effects compared with TMZ therapy alone. The most commonly reported side effect from the delivery of TTFields was a mild-to-moderate skin irritation beneath the transducer arrays.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Newly diagnosed histologically confirmed GBM (WHO-Grade IV)
- •Patient within first 3 cycles of first-line tumor-specific maintenance chemotherapy
- •≥ 18 years of age
- •Clinical indication for TTFields treatment
- •Given informed consent for use and processing of data
排除标准
- •Present or planned pregnancy
- •Significant additional neurological disease (e.g. significantly increased intracerebral pressure (ICP) with a significant midline shift of the brain)
- •Active implanted medical device (e.g. deep brain stimulator)
- •Documented allergy to conductive hydrogel
- •Skull defect (e.g. missing bone with no replacement, bullet fragments in the skull)
结局指标
主要结局
Number of TTFields treatment-related serious adverse events (SAEs) standardized to one year of FU time
时间窗: through study completion, an average of 18 months (mean follow-up time)
Number of TTFields treatment-related SAEs standardized to one year of follow-up (FU) is measured using the collection of SAEs during the follow-up period
Number of SAEs after start of TTFields treatment
时间窗: through study completion, an average of 18 months (mean follow-up time)
Number of SAEs after start of TTFields treatment is measured using the collection of SAEs at the follow-up period
Time of usage (compliance) of TTFields treatment over time
时间窗: through study completion, an average of 18 months (mean follow-up time)
Time of usage (compliance) of TTFields treatment over time is measured using the treatment compliance report at the Follow-up period
Time to first progression of GBM (progression-free survival (PFS)), defined within radiological and/or clinical/neurological assessment during routine clinical care in patients who started TTFields treatment at baseline
时间窗: through study completion, an average of 18 months (mean follow-up time)
Time to first progression of GBM (progression-free survival (PFS)), defined within radiological and/or clinical/neurological assessment during routine clinical care in patients who started TTFields treatment at baseline from date of enrollment until the date of first progression of GBM
Time to death of any cause (overall survival (OS)) from diagnosis
时间窗: through study completion, an average of 18 months (mean FU time)
Time to death of any cause (overall survival (OS)) from diagnosis is measured using the patient data from date of enrollment until the date of death from any cause
Changes in quality of life at month 2 and month 4 after start of TTFields treatment compared to baseline in patients who started TTFields treatment at baseline
时间窗: month 2 and month 4 after start of TTFields treatment compared to baseline in patients who started TTFields treatment at baseline
Changes in quality of life assessed via questionnaires EORTC Quality of life questionnaires (QLQ) QLQ-C30 and BN20 after start of TTFields treatment compared to baseline in patients who started TTFields treatment at baseline is measured using the QoL questionnaires at months two and four after start of TTFields treatment
Patients' reason(s) for refusing TTFields at baseline
时间窗: baseline
Patients' reason(s) for refusing TTFields is measured using a study specific questionnaire at baseline
次要结局
未报告次要终点