Mediastinal LymphomaPROMLYNCT07817641
Proton Therapy for Mediastinal Lymphoma (PROMLY)
A study testing Proton therapy in people with Mediastinal Lymphoma and Hodgkin Disease Lymphoma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The study aims to investigate whether proton therapy is feasible in a national setting and whether proton therapy can reduce the risk of late toxicity (secondary cancers and heart toxicity) compared to foton therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mediastinal Lymphoma, Hodgkin Disease Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL)
- What is being tested?
- Proton therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2026to 1 May 2046
- Phase
- Interventional
- 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
Who may be able to join
- Patients 18 years or older
- Histologically proven Hodgkin or non-Hodgkin lymphoma
- Disease constrained within the mediastinum +/- neck and/or axilla involvement.
- Candidates for curative intended treatment
- Signed written informed consent.
Who cannot join
- Prior radiotherapy to the thorax
- Other current malignancy
- Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Dept. of oncology
Copenhagen, Select A State, 2100
Mogens Bernsdorf, Md. PhD., +4535459681, mogens.bernsdorf@regionh.dk
About this study
The study aims to investigate whether proton therapy is feasible in a national setting and whether proton therapy can reduce the risk of late toxicity (secondary cancers and heart toxicity) compared to foton therapy.
Read the detailed description
Patients are referred for proton therapy based on a reduction of risk of late toxicity which is established on consensus guidelines and multidisciplinary discussions in a study panel/consensus conference. However, this reduction is calculated based on the referring center's treatment planning scan and patient setup.
The aim of this national study is to investigate whether the calculated reduction of risk of toxicity with proton therapy at the referring centers differs from the actual delivered plan at DCPT (ΔNTCP in delivered proton therapy plan versus reference photon plan from referring center).
The study also aims to investigate effect and side effects of proton and photon radiotherapy, including a systematically prospective registration of acute and late side effects and to evaluate the use of a model-based approach to select patients for proton therapy.
- Being tested
- Proton therapy
- Keywords
- proton therapy, mediastinal lymphoma, NTCP, normal tissue complication probability, Hodgkin Lymphoma, Lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Hodgkin Disease, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton therapyRadiation
If selected, patients will recieve protontherapy instead of photon therapy
| Study group | Role | What they receive |
|---|---|---|
| Proton | Experimental | Patients will receive proton therapy based on selection criteria Receives: Radiation: Proton therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between ΔNTCP_expected and ΔNTCP_delivered.
The correlation between ΔNTCP_expected and ΔNTCP_delivered, is an investigation to see whether the ΔNTCP (ΔNTCP_expected) calculated from the planning CT from the refering center, correlates with the ΔNTCP from the actual delivered plan (ΔNTCP_delivered) at the Danish Centre for Particle Therapy.
Measured: From enrollment to end of radiotherapy, average 5 weeks.
Secondary outcomes (1)
Incidence of acute, late toxicity and other events
- Acute toxicity
- Radiation dermatitis
- Cough
- Fatigue
- Dysphagia
Add a 2nd Outcome Measure
- Incidence of:
- secondary cancers (breast and lung)
- other secondary cancers within the radiation field.
- Myocardial infarction
- Other cardiac events
Add a 3rd Outcome Measure C) Overall survival
Add a 4th Outcome Measure D) Recurrence free survival
Measured: From enrollment to 20 years after end of radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 May 2026
- Primary completion1 May 2046 (estimated)
- Study completion1 May 2046 (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 Copenhagen University Hospital, RigshospitaletThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Centre for Particle Therapy, Aarhus University Hospital, Denmark, Aalborg University Hospital, Odense University Hospital
- Responsible party
- Principal investigator, Mogens Bernsdorf, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817641
- Sponsor's protocol ID
- P-2024-17023
- Acronym
- PROMLY
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Therapy for Mediastinal Lymphoma (PROMLY)
- ClinicalTrials.gov ID
- NCT07817641
- Acronym / sponsor ID
- PROMLY / P-2024-17023
- Keywords
- proton therapy, mediastinal lymphoma, NTCP, normal tissue complication probability, Hodgkin Lymphoma, Lymphoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Centre for Particle Therapy, Aarhus University Hospital, Denmark, Aalborg University Hospital, Odense University Hospital
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2046 (estimated)
- Study completion
- 1 May 2046 (estimated)
- First posted
- 14 Sep 2026 (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 study aims to investigate whether proton therapy is feasible in a national setting and whether proton therapy can reduce the risk of late toxicity (secondary cancers and heart toxicity) compared to foton therapy.
Detailed description
Patients are referred for proton therapy based on a reduction of risk of late toxicity which is established on consensus guidelines and multidisciplinary discussions in a study panel/consensus conference. However, this reduction is calculated based on the referring center's treatment planning scan and patient setup.
The aim of this national study is to investigate whether the calculated reduction of risk of toxicity with proton therapy at the referring centers differs from the actual delivered plan at DCPT (ΔNTCP in delivered proton therapy plan versus reference photon plan from referring center).
The study also aims to investigate effect and side effects of proton and photon radiotherapy, including a systematically prospective registration of acute and late side effects and to evaluate the use of a model-based approach to select patients for proton therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton | Experimental | Radiation: Proton therapyPatients will receive proton therapy based on selection criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients 18 years or older
- Histologically proven Hodgkin or non-Hodgkin lymphoma
- Disease constrained within the mediastinum +/- neck and/or axilla involvement.
- Candidates for curative intended treatment
- Signed written informed consent.
Key exclusion criteria (3 listed)
- Prior radiotherapy to the thorax
- Other current malignancy
- Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic.
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 |
|---|---|---|
| Proton therapyIf selected, patients will recieve protontherapy instead of photon therapy | Radiation | Proton |
Primary outcome
Correlation between ΔNTCP_expected and ΔNTCP_delivered.
Time frame: From enrollment to end of radiotherapy, average 5 weeks.
The correlation between ΔNTCP_expected and ΔNTCP_delivered, is an investigation to see whether the ΔNTCP (ΔNTCP_expected) calculated from the planning CT from the refering center, correlates with the ΔNTCP from the actual delivered plan (ΔNTCP_delivered) at the Danish Centre for Particle Therapy.
1 secondary outcome
Incidence of acute, late toxicity and other events
Time frame: From enrollment to 20 years after end of radiation
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 14 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton therapy in people with Mediastinal Lymphoma and Hodgkin Disease Lymphoma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 14 Sep 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 Denmark. 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 Mogens Bernsdorf, Md. Phd (+4535459681, mogens.bernsdorf@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between ΔNTCP_expected and ΔNTCP_delivered. (time frame: From enrollment to end of radiotherapy, average 5 weeks.). 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 14 Sep 2026.