An interventional study of Proton therapy in Mediastinal Lymphoma, Hodgkin Disease Lymphoma and Diffuse Large B Cell Lymphoma (DLBCL), sponsored by Rigshospitalet, Denmark. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Treatment
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.
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.
1,868 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 355 are open to participants now.
This study's planned enrollment of 139 is above the median of 45 across 1,497 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive proton therapy based on selection criteria
Radiation: Proton therapy
If selected, patients will recieve protontherapy instead of photon therapy
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.
Time frame: From enrollment to end of radiotherapy, average 5 weeks.
Incidence of acute, late toxicity and other events
A) Acute toxicity 1. Radiation dermatitis 2. Cough 3. Fatigue 4. Dysphagia Add a 2nd Outcome Measure B) Incidence of: 1. secondary cancers (breast and lung) 2. other secondary cancers within the radiation field. 3. Myocardial infarction 4. Other cardiac events Add a 3rd Outcome Measure C) Overall survival Add a 4th Outcome Measure D) Recurrence free survival
Time frame: From enrollment to 20 years after end of radiation
Radiation dosimetry
Data from the study will be compared between 1\) Patients treated with protons vs patients treated with photons. 2) Data from the study compared to Historical data. 3) NTCP estimated risk vs. actual events (protons and photons).
Time frame: From enrollment to 20 years after end of radiotherapy
Plan to share: No
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for May 2046, 240 months after the start.
Of 40 non-industry interventional studies with no phase under Lymphoma, Large B-Cell, Diffuse, half reached primary completion within 73 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 144. This study's planned 240 months is above that.
Counting every sponsor, half of 41 studies reached it within 73 months; a quarter within 42 and three quarters within 137.
How these figures are worked out, and which studies are left out of them.
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Lymphoma, Large B-Cell, Diffuse →