Mediastinal LymphomaNCT04613388
Registry Study of Proton Radiotherapy in Lymphoma
An observational study of Mediastinal Lymphoma, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mediastinal Lymphoma
- What is being tested?
- Assesment of Effectiveness and side effects
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2018to 1 Aug 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age <18 years
- Non-consent of the patient to the disclosure of his data
- Cancellation of the patient's participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Heidelberg
Heidelberg, 69120
Juergen Debus, Professor, 06221 56 ext. 8201, juergen.debus@med.uni-heidelberg.de
Laila König, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Mediastinal Lymphoma
- Being tested
- Assesment of Effectiveness and side effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assesment of Effectiveness and side effectsOther
Case Report forms, Quality of life questionaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Acquisition and documentation of a mediastinal PT and the corresponding follow-up data
Effectiveness and side effects of proton radiotherapy
Measured: From date of written informed consent until the date of death from any cause, assessed up to 100 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Aug 2018
- Primary completion1 Aug 2030 (estimated)
- Study completion1 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal LymphomaStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Debus, University Hospital Heidelberg
- Investigators
- Laila König, MD, Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613388
- Sponsor's protocol ID
- RadOnk 130718
- Status last verified
- Apr 2026
- First submitted
- 15 Oct 2020
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Registry Study on Proton Radiotherapy for Mediastinal Lymphomas
- ClinicalTrials.gov ID
- NCT04613388
- Acronym / sponsor ID
- RadOnk 130718
- Conditions
- Mediastinal Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2030 (estimated)
- Study completion
- 1 Aug 2031 (estimated)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Age <18 years
- Non-consent of the patient to the disclosure of his data
- Cancellation of the patient's participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assesment of Effectiveness and side effectsCase Report forms, Quality of life questionaire | Other | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laila König, MD principal investigator
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mediastinal Lymphoma, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laila König, MD (+49 6221 ext. 2801, laila.könig@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.