Registry Study of Proton Radiotherapy in Lymphoma

NCT ID: NCT04613388

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2026-08-01

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.

Detailed Description

Improvements in multimodal therapy have resulted in high curation rates in lymphoma patients. In addition, these cancer entities (Hodgkin lymphoma and non-Hodgkin lymphoma) often affect very young patients. Due to the high healing rates, the long-term effects of therapy are increasingly coming into focus: more than 40% of patients suffer from chronic, therapy-associated secondary diseases 30 years after successful therapy [1]. For this reason, an important focus of current research is the reduction of therapy-associated toxicity. A certain trend of dose reduction and reduction of the radiation fields (involved-field, involved-node, involved-site radiation) can already be seen in the research results of the last decades. Another interesting approach to protecting adjacent organs is the use of modern radiation techniques such as particle therapy with protons (PT).

In the case of radiation in the mediastinal area in particular, the use of PT can greatly reduce the dose in the area of the heart muscle, the lungs or the mammary gland tissue compared to conventional radiation with photons. It is hoped that this will result in a decrease, especially in chronic side effects, in the area of these organs. Since this is a group of young patients with intensive pre-treatment with chemotherapeutic agents, a reduction in long-term toxicities is of particular importance. In particular, cardiac and pulmonary long-term side effects as well as a reduction in the secondary malignancy rate play a major role in this collective.

The aim of this prospective registry study on proton radiotherapy for mediastinal lymphomas is to record the frequency, feasibility and side effects after PT in this group of patients. These data should then serve as the basis for concrete therapy recommendations and assessment of side effects. Close cooperation with the study groups should also enable a comparative analysis of comparable patients who were not treated with protons at a later point in time.

Conditions

Mediastinal Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Assesment of Effectiveness and side effects

Case Report forms, Quality of life questionaire

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Age <18 years

• Non-consent of the patient to the disclosure of his data
• Cancellation of the patient's participation in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Juergen Debus

Head of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laila König, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

University Hospital Heidelberg

Heidelberg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Laila König, MD

Role: CONTACT

laila.könig@med.uni-heidelberg.de

+49 6221 ext. 2801

Adriane Hommertgen, Phd

Role: CONTACT

adriane.hommertgen@med.uni-heidelberg.de

+49 6221 ext. 2801

Facility Contacts

Juergen Debus, Professor

Role: primary

juergen.debus@med.uni-heidelberg.de

06221 56 ext. 8201

Other Identifiers

RadOnk 130718

Identifier Type: -

Identifier Source: org_study_id