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临床试验/NCT04613388
NCT04613388
招募中
不适用

Multicenter Registry Study on Proton Radiotherapy for Mediastinal Lymphomas

University Hospital Heidelberg2 个研究点 分布在 1 个国家目标入组 200 人2018年8月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Mediastinal Lymphoma
发起方
University Hospital Heidelberg
入组人数
200
试验地点
2
主要终点
Acquisition and documentation of a mediastinal PT and the corresponding follow-up data
状态
招募中
最后更新
3天前

概览

简要总结

The aim is to record and document a mediastinal PT and the corresponding follow-up data (effectiveness and side effects). General recommendations for planning and feasibility are made within the framework of this study.

详细描述

Improvements in multimodal therapy have resulted in high curation rates in lymphoma patients. In addition, these cancer entities (Hodgkin lymphoma and non-Hodgkin lymphoma) often affect very young patients. Due to the high healing rates, the long-term effects of therapy are increasingly coming into focus: more than 40% of patients suffer from chronic, therapy-associated secondary diseases 30 years after successful therapy \[1\]. For this reason, an important focus of current research is the reduction of therapy-associated toxicity. A certain trend of dose reduction and reduction of the radiation fields (involved-field, involved-node, involved-site radiation) can already be seen in the research results of the last decades. Another interesting approach to protecting adjacent organs is the use of modern radiation techniques such as particle therapy with protons (PT). In the case of radiation in the mediastinal area in particular, the use of PT can greatly reduce the dose in the area of the heart muscle, the lungs or the mammary gland tissue compared to conventional radiation with photons. It is hoped that this will result in a decrease, especially in chronic side effects, in the area of these organs. Since this is a group of young patients with intensive pre-treatment with chemotherapeutic agents, a reduction in long-term toxicities is of particular importance. In particular, cardiac and pulmonary long-term side effects as well as a reduction in the secondary malignancy rate play a major role in this collective. The aim of this prospective registry study on proton radiotherapy for mediastinal lymphomas is to record the frequency, feasibility and side effects after PT in this group of patients. These data should then serve as the basis for concrete therapy recommendations and assessment of side effects. Close cooperation with the study groups should also enable a comparative analysis of comparable patients who were not treated with protons at a later point in time.

注册库
clinicaltrials.gov
开始日期
2018年8月1日
结束日期
2031年8月1日
最后更新
3天前
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Juergen Debus

Head of Department

University Hospital Heidelberg

入排标准

入选标准

  • Histologically confirmed lymphoma according to WHO
  • Patient consent
  • Patient age ≥18 years.
  • Presence of the need for mediastinal radiotherapy and the presumed benefit of mediastinal radiotherapy using protons in comparison to photon radiation (e.g. improved heart, lungs, and breast protection compared to photon radiation).
  • Ability of the patient to give consent

排除标准

  • Age \<18 years
  • Non-consent of the patient to the disclosure of his data
  • Cancellation of the patient's participation in the study

结局指标

主要结局

Acquisition and documentation of a mediastinal PT and the corresponding follow-up data

时间窗: From date of written informed consent until the date of death from any cause, assessed up to 100 month

Effectiveness and side effects of proton radiotherapy

研究点 (2)

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