Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma - A Randomised Phase III Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 试验地点
- 43
- 主要终点
- Proportion of patients with distant intracranial failure as determined by magnetic resonance imaging (MRI) assessment
研究概览
简要总结
People with brain metastases from melanoma are offered different treatment options after local treatment of their brain metastases via surgery or stereotactic irradiation. Depending on the treating institution and the clinician involved a patient may or may not be offered whole brain radiotherapy (WBRT) after their brain metastases are excised or treated with stereotactic irradiation. This trial seeks to determine if WBRT reduces the spread of brain metastases and lengthens the time to recurrence. The trial also examines the effect of WBRT on quality of life and brain functions such as memory, speech and concentration. Participants will be randomised after local treatment of their brain metastases to either WBRT or observation. 220 people will be recruited from sites in Australia, Norway, the UK, the US and other international sites.
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
- •1-3 intracranial metastases on MRI from melanoma, locally treated with either surgical excision and/or stereotactic irradiation.
- •Life expectancy of at least 6 months
- •Aged 18 years or older
- •WBRT must begin within 8 weeks of completion of localised treatment and within 4 weeks of randomisation
- •Able to have an MRI brain scan with contrast. Estimated Glomerular Filtrate Rate (eGFR) is adequate at the discretion of the radiologist and capable of having gadolinium-containing contrast medium for MRI as per practice guidelines
- •Complete localised treatment of all these metastases no more than 6 weeks prior to randomisation
- •An Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less at randomisation
- •CT scan of chest, abdomen and pelvis as a minimum prior to randomisation. Scans must be within 12 weeks of randomisation
- •Serum Lactate Dehydrogenase (LDH) must be = or < 2 x upper limit of normal
- •Able to provide written informed consent
排除标准
- •Any untreated intracranial disease
- •Any previous intracranial treatment (surgical excision and/or stereotactic irradiation treatment and/or WBRT) prior to this diagnosis of intracranial melanoma
- •Evidence of leptomeningeal disease on pre-local treatment MRI scan
- •Patients with prior cancers, except:
- •Those diagnosed more than five years ago with no evidence of disease recurrence within this time;
- •Successfully treated basal cell and squamous cell skin carcinoma;
- •Carcinoma in-situ of the cervix
- •A medical or psychiatric condition that compromises ability to give informed consent or complete the protocol
- •Positive urine pregnancy test for women of childbearing potential within a week of registration onto the trial
结局指标
主要结局
Proportion of patients with distant intracranial failure as determined by magnetic resonance imaging (MRI) assessment
时间窗: 12 months post randomisation
次要结局
- Quality of life as measured by EORTC QLQ-C30 and BN-20(At baseline and every 2 months post randomisation)
- Time to intracranial failure (local, distant and overall) as determined by MRI(Post randomisation to intracranial failure)
- Overall survival(Post randomisation to death from any cause)
- Performance status as measured by ECOG(At baseline and every 2 months post randomisation)
- Incremental cost effectiveness ratio (ICER)(At 12 months from randomisation)
- Neurocognitive function as measured by Hopkins Verbal Learning Test, Controlled Oral Word Association Test, Trail Making Test Part A & B, Stroop - Colour and Word Test and Digit Span (Forwards and Backwards).(At baseline and every 2 months post randomisation)