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NCT Number: NCT04613388

Registry Study of Proton Radiotherapy in Lymphoma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Heidelberg

Heidelberg, 69120, Germany

Location status: Recruiting

Location contact

Juergen Debus, Professor

CONTACT

[email protected]

06221 56 ext. 8201

Laila König, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assesment of Effectiveness and side effects

Other

Case Report forms, Quality of life questionaire

Primary outcomes

  1. 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

    Effectiveness and side effects of proton radiotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Adriane Hommertgen, Phd

CONTACT

[email protected]

+49 6221 ext. 2801

Laila König, MD

CONTACT

laila.kö[email protected]

+49 6221 ext. 2801

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Official study title

Multicenter Registry Study on Proton Radiotherapy for Mediastinal Lymphomas

Important dates

Study start
2018
Primary completion
2030
Study completion
2031
First posted
Nov 3, 2020
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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