Short Term Outcomes After PRoton and PhotoN RadiOtherapy for IDH Mutated Grade 2 and 3 Gliomas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Next intervention-free survival
研究概览
简要总结
Rationale:
Proton beam therapy has recently become available for the treatment of patients with WHO grade 2 and 3 IDH mutated (IDHmt) glioma in the Netherlands. The dose distributions associated with proton therapy have substantially reduced the volume of the normal brain irradiated with low and intermediate radiotherapy doses. Whether this impacts rates of progressive disease or safety issues and how this compares with a similar population treated with photon therapy is currently unknown.
Objective:
To investigate short term outcomes after proton and photon radiotherapy for grade 2 and 3 IDHmt glioma.
详细描述
Patients with grade 2 and 3 IDHmt glioma treated with proton therapy in Holland PTC, Maastro and UMC Groningen and referred Erasmus MC, Haaglanden MC, LUMC, Amsterdam UMC, Verbeeten Institute, Maastro, UMC Groningen, and Leuven University Hospital between 1st of January 2018 and the 30th of June 2022. The outcomes will be compared to those from patients with grade 2 and 3 IDHmt glioma treated with photon therapy in the same institutes and during the same period of time. The applied clinical target volume (CTV) margins and the chemotherapy are preferably similar for proton and photon therapy.
Retrospective data will be collected from the electronic records of each participating institute. For the primary outcome, data will be collected on interventions (radiotherapy, surgery, chemotherapy, medication) for either tumor progression or toxicity after radiotherapy. This will be used to calculate next intervention free survival as primary outcome.
For the secondary outcomes, data on survival, disease progression, pseudoprogression, and toxicity will be used to calculate overall survival, progression free survival, and pseudoprogression free survival, as well as toxicity incidence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Histopathologically confirmed WHO grade 2 or grade WHO 3 IDHmt glioma
- •Treatment with radiotherapy delivered between 1 of January 2018 and completed before or on the 30th of June 2022
- •Treatment with chemotherapy delivered after radiotherapy (PCV or Temozolomide)
- •Age ≥ 18 years
排除标准
- •Prior cranial radiotherapy
- •Contra-indication for MRI imaging
- •Chemotherapy delivered before radiotherapy
- •Dose and fractionation other that standard dose (50.4 Gy in 28 fractions for Grade 2 and 59.5 Gy in 33 fractions for Grade 3)
- •Combination photon and proton therapy
- •Patient has previously opted-out of the use of their data for research
结局指标
主要结局
Next intervention-free survival
时间窗: 24 months
Time from the last day of radiotherapy until the start of a new next intervention. Next intervention is defined as either neurosurgical re-operation, re-irradiation, start of new chemotherapy (other than the standard adjuvant chemotherapy), start of VGEF inhibitors such as bevacizumab, or new start of dexamethasone for either tumor progression or radiotherapy effects.
次要结局
- Adverse Events(24 months)
- Overall survival(24 months)
- Progression-free survival(24 months)
- Pseudoprogression-free survival(24 months)
研究者
Alejandra Mendez Romero
Principal Investigator
Erasmus Medical Center