UNITy-BasED MR-Linac Adaptive Simultaneous Integrated Hypofractionated Boost Trial for High Grade Glioma in the Elderly
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Progression-free survival at 6 months following chemoradiation
研究概览
简要总结
The usual standard of care for patients over 65 diagnosed with glioblastoma ("GBM") or Grade 4 astrocytoma, IDH-mutant is a 3-week course of radiotherapy, with concurrent and adjuvant temozolomide (TMZ). This radiation dose and length of treatment are less than what would be given for younger patients, primarily due to unclear survival benefits from randomized trials. However, survival remains dismal, and may be partially due to the reduced radiation dose. Recent studies investigating this have found that increased radiation dose (to the equivalent of what is normally given over 6 weeks in younger patients) over 3 weeks is well-tolerated and has improved survival rates.
Additionally, with the advent of novel technology such as the MR-Linac, adaptive radiotherapy with this regimen using reduced radiation margins is possible. Use of the MR-Linac allows for daily MRI scans to be done prior to treatment, so plans can be adapted to tumour dynamics and anatomical deformations. In this trial, we will examine the outcomes of increased radiation dose, combined with reduced-margin adaptive radiotherapy in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age ≥ 65 years
- •Histopathologically confirmed, based on biopsy or surgical resection, glioblastoma or WHO grade 4 astrocytoma, IDH-mutant
- •Biopsy or surgical resection performed ≤ 6 weeks prior to study entry
- •Deemed suitable by the treating physicians for 15 daily fractions of radiation, delivered daily over 3 weeks, with concurrent temozolomide chemotherapy
- •Expected survival ≥ 12 weeks
- •ECOG performance status of 0, 1 or 2
- •Able (sufficiently fluent in English) and willing to complete QOL questionnaires; however, inability to complete the questionnaires will not make the patient ineligible for the study
- •Sufficient estimated glomerular filtration rate (eGFR) of ≥ 30 mL/min/1.73 m2 to allow administration of gadolinium-based contrast agent; patients with eGFR < 30 mL/min/1.73 m2 not on dialysis may be allowed on the study after discussion of risks and benefits and approval by study neuroradiologist(s)
- •Completed written informed consent
- •Patient must be accessible for treatment and follow-up
排除标准
- •Contraindications to MRI as per standard MRI screening policy
- •Contraindication to Gadolinium-based contrast media
- •Inability to lie flat in a supine position for at least 90 minutes
- •Inability to tolerate immobilization in a head thermoplastic mask
- •Patients > 140 kg and/or a circumference > 60 cm
- •Prior dose-limiting cranial irradiation
- •T1w post-gadolinium enhancing disease involving the brainstem
- •Leptomeningeal dissemination of disease
- •Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol
研究组 & 干预措施
Treatment Arm
Concurrent dose-escalated chemoradiation with temozolomide (TMZ) on the MR-Linac with weekly adaptation
干预措施: Dose escalation + Reduced Margin Adaptive Radiotherapy (Radiation)
结局指标
主要结局
Progression-free survival at 6 months following chemoradiation
时间窗: 6 months from study entry date
次要结局
- Toxicity and Health-related Quality of Life Changes based on the EORTC QLQ-BN20(Through study completion, an average of 9 months)
- Compare differences in adaptive vs non-adaptive with regards to organ-at-risk doses(6-12 months)
- Compare differences in adaptive vs non-adaptive with regards to length of radiation treatment time(6-12 months)
- Progression-free survival(Through study completion, an average of 5 months)
- Overall survival(Through study completion, an average of 9 months)
- Toxicity and Health-related Quality of Life Changes based on the EORTC QLQ-C30(Through study completion, an average of 9 months)
- Compare differences in adaptive vs non-adaptive with regards to cumulative dose(6-12 months)
- Functional Imaging Kinetics as a Correlate of Treatment Response(12-24 months)
- Patterns of Failure(Through study completion, an average of 5 months)
- Local control(Through study completion, an average of 5 months)
- Compare differences in adaptive vs non-adaptive with regards to treatment volume(6-12 months)
研究者
Chia-Lin (Eric) Tseng
Assistant Professor of Radiation Oncology
Sunnybrook Health Sciences Centre