Proton Therapy for Mediastinal Lymphoma (PROMLY)

NCT07817641 | Recruiting DMC

• 1 other identifier: P-2024-17023
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mediastinal Lymphoma; Diffuse Large B Cell Lymphoma (DLBCL); Hodgkin Disease Lymphoma

Keywords

proton therapy; mediastinal lymphoma; NTCP; normal tissue complication probability; Hodgkin Lymphoma; Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to end of radiotherapy, average 5 weeks.

Secondary Outcomes (1)

• Incidence of acute, late toxicity and other events

  From enrollment to 20 years after end of radiation

Other Outcomes (1)

• Radiation dosimetry

  From enrollment to 20 years after end of radiotherapy

Study Arms (1)

Proton

EXPERIMENTAL

Patients will receive proton therapy based on selection criteria

Radiation: Proton therapy

Interventions

Proton therapy RADIATION

If selected, patients will recieve protontherapy instead of photon therapy

Proton

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prior radiotherapy to the thorax
• Other current malignancy
• Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Centre for Particle Therapy, Aarhus University Hospital, Denmark: collaborator
• Aalborg University Hospital: collaborator
• Odense University Hospital: collaborator

Study Sites (1)

Dept. of oncology

Copenhagen, Select A State, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Hodgkin Disease; Lymphoma

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Central Study Contacts

Mogens Bernsdorf, Md. Phd

CONTACT

+4535459681; mogens.bernsdorf@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: September 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2046
• Study Completion (Estimated): May 1, 2046
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)