Evaluation of the Contribution of Multicenter Expertise (Radiotherapists and Physicists) and Use of Deformable Fusion Software Allowing the Accumulation of Doses in Equivalent Dose 2 Grays for Re-irradiations With Curative Intent
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 29
- 主要终点
- Rate of patients for whom the intervention has changed the treatment plan
研究概览
简要总结
We propose to evaluate the contribution of a standardized process combining,
- a validation of re-irradiation indications by a group of multi-professional experts (radiotherapists and physicists) and,
- a collective validation of the accumulation of doses on all the organs of the anatomical region concerned obtained using deformable fusion software (MiM) allowing the accumulation of doses in terms of Equivalent Dose 2 Grays (EQD2).
The primary objective of this study is to determine the rate of patients for whom this process has changed the treatment plan.
详细描述
Recent clinical data confirm the possibility and clinical benefit of delivering a second irradiation with curative intent even if the commonly accepted maximum doses to OARs had been reached during the first irradiation.
However, there is no consensus on acceptable doses to AORs in a re-irradiation context. The difficulty of making decisions and validating dosimetry may limit access to treatment. Re-irradiations are therefore carried out according to local experience and equipment, resulting in territorial inequality.
MiM software is an innovative software dedicated to images registration and dose summation. It allows the EQD2 doses of the various irradiations to be cumulated.
Recruitment and inclusion step: For each included patient (signed consent form), the center provides an initial opinion concerning the indication for re-irradiation with curative intent (Opinion 1).
Indication and pre-dosimetric study step:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age ≥ 18 years when signing the consent form
- •Re-irradiation with desired curative intent (≥ 50 Gy EQD2), with volume to be irradiated totally or partially included in a previous irradiation field:
- •Oligo-metastases or oligo-progression (< 5 metastases in less than 3 sites)
- •Second cancer
- •Isolated local recurrence
- •Life expectancy > 6 months
- •Dated and signed informed consent
- •Affiliation to a social security scheme or equivalent
排除标准
- •Indication of intracranial, prostate, rectum or esophagus re-irradiation
- •Diagnosis of multi-metastatic cancer
- •PS ECOG ≥ 2
- •Impossibility to interrupt current treatment with a tyrosine kinase inhibitor or other systemic treatment (excluding hormonal therapy) which may potentiate the rays effects (duration of wash-out according to treatment instructions)
- •Pregnant or breastfeeding women
- •Tutorship or curatorship or deprivation of liberty
研究组 & 干预措施
Multidisciplinary and multicenter validation of re-irradiation with curative intent
Validation by a multicenter group of multi-professional experts (radiotherapists and physicists) of:
- re-irradiation indication
- EQD2 cumulated doses using MiM
干预措施: Multidisciplinary and multicenter validation of re-irradiation with curative intent (Other)
结局指标
主要结局
Rate of patients for whom the intervention has changed the treatment plan
时间窗: Up to 3 months
Defined as the rate of patients for whom: * Re-irradiation at curative doses is finally possible while initially deemed unfeasible, * or validated median dose to GTV is increased by at least 5% compared to the initially envisaged dose, * or doses constraints to OARs are modified, * or the envisaged re-irradiation is invalidated.
次要结局
- Late safety of re-irradiation(Up to 24 months)
- Local control rate at 3 months(At 3 months)
- Local control rate at 6 months(At 6 months)
- Local control rate at 12 months(At 12 months)
- Local control rate at 24 months(At 24 months)
- Time required for fusion and dose summation(Up to 3 months)
- Benefit of deformable registration(Up to 3 months)
- Rate of patients having received the proposed validated dose(Up to 5 months)
- Rate of patients without treatment-related toxicity or local progression or death at 2 years(Up to 24 months)
- Rate of change in centre practices(Up to 48 months)