Proton Therapy for Mediastinal Lymphoma (PROMLY)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Correlation between ΔNTCP_expected and ΔNTCP_delivered.
研究概览
简要总结
The study aims to investigate whether proton therapy is feasible in a national setting and whether proton therapy can reduce the risk of late toxicity (secondary cancers and heart toxicity) compared to foton therapy.
详细描述
Patients are referred for proton therapy based on a reduction of risk of late toxicity which is established on consensus guidelines and multidisciplinary discussions in a study panel/consensus conference. However, this reduction is calculated based on the referring center's treatment planning scan and patient setup.
The aim of this national study is to investigate whether the calculated reduction of risk of toxicity with proton therapy at the referring centers differs from the actual delivered plan at DCPT (ΔNTCP in delivered proton therapy plan versus reference photon plan from referring center).
The study also aims to investigate effect and side effects of proton and photon radiotherapy, including a systematically prospective registration of acute and late side effects and to evaluate the use of a model-based approach to select patients for proton therapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years or older
- •Histologically proven Hodgkin or non-Hodgkin lymphoma
- •Disease constrained within the mediastinum +/- neck and/or axilla involvement.
- •Candidates for curative intended treatment
- •Signed written informed consent.
排除标准
- •Prior radiotherapy to the thorax
- •Other current malignancy
- •Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic.
研究组 & 干预措施
Proton
Patients will receive proton therapy based on selection criteria
干预措施: Proton therapy (Radiation)
结局指标
主要结局
Correlation between ΔNTCP_expected and ΔNTCP_delivered.
时间窗: From enrollment to end of radiotherapy, average 5 weeks.
The correlation between ΔNTCP\_expected and ΔNTCP\_delivered, is an investigation to see whether the ΔNTCP (ΔNTCP\_expected) calculated from the planning CT from the refering center, correlates with the ΔNTCP from the actual delivered plan (ΔNTCP\_delivered) at the Danish Centre for Particle Therapy.
次要结局
- Incidence of acute, late toxicity and other events(From enrollment to 20 years after end of radiation)
研究者
Mogens Bernsdorf
MD, PhD
Rigshospitalet, Denmark