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Recruiting NCT04613388

Registry Study of Proton Radiotherapy in Lymphoma

Observational Mediastinal Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Assesment of Effectiveness and side effects.
Who it may be relevant to
Registry conditions: Mediastinal Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Multicenter Registry Study on Proton Radiotherapy for Mediastinal Lymphomas

Overview

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.

Detailed description

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.

Interventions

  • Other Assesment of Effectiveness and side effects
    Case Report forms, Quality of life questionaire

Primary outcome measures

  • Acquisition and documentation of a mediastinal PT and the corresponding follow-up data [Time frame: From date of written informed consent until the date of death from any cause, assessed up to 100 month]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

Age <18 years

  • Non-consent of the patient to the disclosure of his data
  • Cancellation of the patient's participation in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • University Hospital Heidelberg — Heidelberg

Identifiers

NCT: NCT04613388 · RadOnk 130718

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗