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JOURNAL ONKOLOGIE – STUDIE

Registry Study of Proton Radiotherapy in Lymphoma

Rekrutierend

NCT-Nummer:
NCT04613388

Studienbeginn:
August 2018

Letztes Update:
03.11.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Lymphoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Heidelberg

Collaborator:
-

Studienleiter

Laila König, MD
Principal Investigator
University Hospital Heidelberg

Kontakt

Laila König, MD
Kontakt:
Phone: +49 6221
Phone (ext.): 2801
E-Mail: laila.könig@med.uni-heidelberg.de
» Kontaktdaten anzeigen
Adriane Hommertgen, Phd
Kontakt:
Phone: +49 6221
Phone (ext.): 2801
E-Mail: adriane.hommertgen@med.uni-heidelberg.de
» Kontaktdaten anzeigen

Studienlocations (1 von 1)

University Hospital Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Juergen Debus, Professor
Phone: 06221 56
Phone (ext.): 8201
E-Mail: juergen.debus@med.uni-heidelberg.de
» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Acquisition and documentation of a mediastinal PT and the corresponding follow-up data (Time Frame - From date of written informed consent until the date of death from any cause, assessed up to 100 month):
Effectiveness and side effects of proton radiotherapy

Geprüfte Regime

  • Assesment of Effectiveness and side effects:
    Case Report forms, Quality of life questionaire

Quelle: ClinicalTrials.gov


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