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NCT Number: NCT07817641

Proton Therapy for Mediastinal Lymphoma (PROMLY)

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.

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Key information

Conditions

Mediastinal Lymphoma Diffuse Large B Cell Lymphoma (DLBCL) Hemic and Lymphatic Diseases Hodgkin Disease Hodgkin Disease Lymphoma Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of oncology

Copenhagen, Select A State, 2100, Denmark

Location status: Recruiting

Location contact

Mogens Bernsdorf, Md. PhD.

CONTACT

[email protected]

+4535459681

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

proton therapy

Radiation

If selected, patients will recieve protontherapy instead of photon therapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of acute, late toxicity and other events

    Time frame: From enrollment to 20 years after end of radiation

    A) Acute toxicity

    • Radiation dermatitis
    • Cough
    • Fatigue
    • Dysphagia

    Add a 2nd Outcome Measure

    B) 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

Other outcomes

  1. Radiation dosimetry

    Time frame: From enrollment to 20 years after end of radiotherapy

    Data from the study will be compared between

    • 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Mogens Bernsdorf, Md. Phd

CONTACT

[email protected]

+4535459681

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Aalborg University Hospital
  • Danish Centre for Particle Therapy, Aarhus University Hospital, Denmark
  • Odense University Hospital

Registry information

Acronym: PROMLY

Important dates

Study start
2026
Primary completion
2046
Study completion
2046
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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