Clinical trial NCT04613388: Registry Study of Proton Radiotherapy in Lymphoma
Official title: Multicenter Registry Study on Proton Radiotherapy for Mediastinal Lymphomas
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mediastinal Lymphoma
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Acquisition and documentation of a mediastinal PT and the corresponding follow-up data
timeFrame: From date of written informed consent until the date of death from any cause, assessed up to 100 month
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
Study officials:
affiliation: University Hospital Heidelberg
name: Laila König, MD
role: PRINCIPAL_INVESTIGATOR
References: