Registry Study of Proton Radiotherapy in Lymphoma

NCT04613388 | Recruiting

• 1 other identifier: RadOnk 130718
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to record and document a mediastinal PT and the corresponding follow-up data (effectiveness and side effects). General recommendations for planning and feasibility are made within the framework of this study.

Conditions

Mediastinal Lymphoma

Outcome Measures

Primary Outcomes (1)

• Acquisition and documentation of a mediastinal PT and the corresponding follow-up data

  Effectiveness and side effects of proton radiotherapy

  From date of written informed consent until the date of death from any cause, assessed up to 100 month

Interventions

Assesment of Effectiveness and side effects OTHER

Case Report forms, Quality of life questionaire

Eligibility Criteria

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

Study Population

Patients with mediastinal lymphoma are recorded who require consolidating mediastinal radiotherapy as part of their primary therapy. Since there is no intervention in the registry study, patients who are being treated in a therapy study (e.g. in the context of the ongoing Hodgkin studies) can also be included.

You may qualify if:

• Histologically confirmed lymphoma according to WHO
• Patient consent
• Patient age ≥18 years.
• Presence of the need for mediastinal radiotherapy and the presumed benefit of mediastinal radiotherapy using protons in comparison to photon radiation (e.g. improved heart, lungs, and breast protection compared to photon radiation).
• Ability of the patient to give consent

You may not qualify if:

• Age \<18 years
• Non-consent of the patient to the disclosure of his data
• Cancellation of the patient's participation in the study

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University Hospital Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Study Officials

• Laila König, MD

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laila König, MD

CONTACT

+49 6221; laila.könig@med.uni-heidelberg.de

Adriane Hommertgen, Phd

CONTACT

+49 6221; adriane.hommertgen@med.uni-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: November 3, 2020
• Study Start: August 1, 2018
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2031
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)