RE-irradiation of Diffuse MIdline Glioma paTients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 59
- 主要终点
- To evaluate the safety of re-irradiation (reRT)
研究概览
简要总结
The REMIT (RE-irradiation of diffuse MIdline glioma paTients) study evaluates safety and the palliative efficacy of re-irradiation of patients with diffuse midline glioma (DMG). The study will introduce a standard re-irradiation treatment schedule for DMG patients who have progressed following primary treatment.
详细描述
REMIT is a non-randomized, prospective, investigator-initiated, phase II, multi-centre observational study with two inclusion groups, arm A and B. Arm A and B will be offered the same treatment.
Patients treated with primary radiotherapy 54Gy/30 fractions, either enrolled in the BIOMEDE 2.0 protocol or not, will be included in Arm A. DMG patients treated with any other total dose and fractionation than 54Gy/30F will be included in Arm B. The re-RT and follow up will be the same in both arms.
As treatment 20Gy/10 fractions is given as first time re-irradiation with extended follow up on toxicity, performance status and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Primary radiotherapy treatment
入排标准
- 年龄范围
- 12 Months 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diffuse midline glioma diagnosis: verified radiologically or histologically Biopsy is not mandatory for REMIT
- •Age ≥ 12 months to ≤21 years.
- •Min. 180 days/6 months have elapsed from the first day of the 1st RT course
- •1st course of radiotherapy
- •Full recovery from all acute and subacute toxicities of 1st RT course
- •Clinical progression of symptoms and/or radiographic progression
- •Karnofsky performance status scale or Lansky Play Scale > 50% The performance status should not take the neurological deficits per se into account.
- •NB: Children and adults with a worsening performance status due to glioma-related motor deficit can be included.
- •Life expectancy > 12 weeks after start of reRT
- •Signed informed consent by patient and/or parents or legal guardian
排除标准
- •Presence of leptomeningeal spread or multifocal disease on MRI at progression
- •Other co-morbidity that according to the treating physician would impair participation in the study
- •>1 course of radiotherapy
- •Neurofibromatosis type 1
- •Inability to complete the medical follow-up (geographic, social, or mental reasons)
结局指标
主要结局
To evaluate the safety of re-irradiation (reRT)
时间窗: 4 weeks after end of re-irradiation
The primary endpoint will be the cumulative incidence of grade ≥4 CTCAE (The NCI Common Terminology Criteria for Adverse Events) events measured 4 weeks after the last day of reRT.
次要结局
- The key secondary objective is to prospectively validate the palliative efficacy of reRT of DMG. Palliative efficacy is evaluated by two endpoints: overall survival and symptom relief.(4 weeks after end of re-irradiation)
- Palliative efficacy measured as symptom relief(4 weeks after end of re-irradiation)
- Other secondary outcomes(through study completion)
研究者
Maja Maraldo
Consultant, Head of breast and paediatric radiotherapy
Rigshospitalet, Denmark