| Registry | NCT07817641, acronym PROMLY |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 139 (Estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet (Other); collaborators: Danish Centre for Particle Therapy, Aarhus University Hospital, Denmark, Aalborg University Hospital, Odense University Hospital |
| Conditions | Mediastinal Lymphoma, Hodgkin Disease Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL) |
| Interventions | Proton therapy (Radiation) |
| Dates | start 2026-05-01, primary completion 2046-05-01 (estimated), completion 2046-05-01 (estimated), first posted 2026-09-14, last updated 2026-09-14 |
| Locations | 1 site in Denmark |
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All trials for Mediastinal Lymphoma All trials for Hodgkin Disease Lymphoma All trials of Proton therapy
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Proton | Experimental | Radiation: Proton therapy | Patients will receive proton therapy based on selection criteria |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * 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. Exclusion Criteria: * Prior radiotherapy to the thorax * Other current malignancy * Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic.
| Facility | City | Country | Status |
|---|---|---|---|
| Dept. of oncology | Copenhagen, Select A State | Denmark | Recruiting |