Registry Study of Proton Radiotherapy in Lymphoma

Multicenter Registry Study on Proton Radiotherapy for Mediastinal Lymphomas

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.

Study Overview

• Status: Recruiting
• Conditions: Mediastinal Lymphoma
• Intervention / Treatment: Other: Assesment of Effectiveness and side effects

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Laila König, MD; Phone Number: 2801 +49 6221; Email: laila.könig@med.uni-heidelberg.de
• Study Contact Backup: Name: Adriane Hommertgen, Phd; Phone Number: 2801 +49 6221; Email: adriane.hommertgen@med.uni-heidelberg.de

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • University Hospital Heidelberg
    • Contact: Juergen Debus, Professor; Phone Number: 8201 06221 56; Email: juergen.debus@med.uni-heidelberg.de
    • Principal Investigator: Laila König, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with mediastinal lymphoma are recorded who require consolidating mediastinal radiotherapy as part of their primary therapy. Since there is no intervention in the registry study, patients who are being treated in a therapy study (e.g. in the context of the ongoing Hodgkin studies) can also be included.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acquisition and documentation of a mediastinal PT and the corresponding follow-up data	Effectiveness and side effects of proton radiotherapy	From date of written informed consent until the date of death from any cause, assessed up to 100 month

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Investigators: Principal Investigator: Laila König, MD, University Hospital Heidelberg

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2031

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: RadOnk 130718

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No