Prospective Randomized Phase II Trial of Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- progression free survival
研究概览
简要总结
Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. The treatment comprises maximal safe resection followed by radiotherapy and chemotherapy. Despite appropriate management, 90% of the patients will develop relapse or progression. After progression, the median survival is 5.2 months (Stupp, 2009).
The treatment of GBM relapse remains investigational. Reirradiation is an option in selected cases.
The objective of this study is to compare 2 schemes of stereotactic hypofractionated radiotherapy in the management of recurrent GBM.
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
- Double (Participant, Outcomes Assessor)
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
- •18 years of age or older
- •KPS equal or greater than 60
- •Anatomopathological confirmation of GBM
- •Previous RT with therapeutic doses
- •At least 5 months from the end of RT course
- •Not a candidate to surgical resection
- •Patients with partial resection after resection of recurrent GBM will be allowed
- •Patients with local progression after resection of recurrent GBM will be allowed
- •Lesion with a maximal 150cc volume, as defined by enhancing portion in contrast enhanced MRI
- •Hemoglobin levels (Hb) equal or greater than 10ng/dl. Blood transfusions to correct the Hb will be allowed.
排除标准
- •Important comorbidities
- •Concomitant chemotherapy
- •Contraindication to MRI
- •Brainstem glioma
结局指标
主要结局
progression free survival
时间窗: from date of randomization until date of first documented progression or death from any cause, which ever comes first, assessed up to 48 months
progression free survival as defined by the "Response Assesment in Neuro Oncology Working Group"(Wen, 2010). Briefly progression is defined as: * increase in 25% of the product of perpendicular diameters of enhancing lesions * significant increase in T2/Flair non enhancing component * appearance of new lesions * clinical deterioration not attributable to other causes other than the tumor or reduction in corticosteroid dose
次要结局
- local control(from date of randomization until date of local progression, assessed up to 48 months)
- toxicity(from date of randomization until death, assessed up to 48 months)
- overall survival(from date of randomization until death from any cause, assessed up to 48 months)
- quality of life(from date of randomization until last follow-up, assessed up to a period of 48 months)
研究者
Andre Tsin Chih Chen
Medical Doctor
University of Sao Paulo