RadOnk 130718Recruiting

Observational Study on Proton Radiation for Thoracic Lymphomas: A Gentle Radiation Treatment for Young Patients?

Gender
Women and men
Age
18 years and older
Trial type
Observational
Line of therapy
First line
Phase

What is this trial about?

Mediastinal lymphomas are a type of lymphoma that occurs in the chest cavity between the lungs. Radiation therapy is often used to treat this condition. This treatment involves the use of photons and protons, which have different radiation properties. The goal of the RadOnk 130718 study is to conduct an observational comparison of the efficacy and side effects of photon radiation therapy and proton radiation therapy. The study is not testing a new therapy, and the type of radiation therapy is not determined as part of the study. Eligible participants include women and men aged 18 and older with a confirmed diagnosis of mediastinal lymphoma who are scheduled to receive proton therapy as part of their treatment.

Trial flow

Requirements

Diagnosis: mediastinal lymphoma

Age: 18 years and older

Line of therapy: Erstlinie / bisher keine Therapie

Key inclusion criteria: histologically confirmed; indication for mediastinal radiation therapy as first line treatment as part of standard therapy or as part of a clinical trial

Allocation

Einarmigen Studie

Treatment

proton therapy

Follow-up

100 months

Detailed description

Lymphomas are malignant diseases affecting a subtype of white blood cells that are part of the body’s immune system. These diseases can take various forms, but they are generally systemic in nature—that is, they affect the entire body. However, lymphoma can also occur in specific regions of the body, such as the mediastinum—the space between the lungs that contains, among other structures, the heart, major blood vessels, the trachea, and the esophagus. Radiation therapy is a common method for treating mediastinal lymphomas, in which targeted radiation is used to destroy tumor cells. A distinction is made between two forms: conventional photon therapy and modern proton therapy. In photon therapy, X-rays are used; while they target the tumor, they also irradiate healthy tissue in front of and behind the tumor. Proton therapy, on the other hand, uses charged particles (protons) that deliver their radiation precisely within the tumor and do not release any further energy afterward—this spares surrounding organs such as the heart or lungs. This more precise method is used primarily for young patients or for tumors in sensitive areas of the body. While photon therapy is more widely available and less expensive, proton therapy can significantly reduce side effects; however, it is technically more complex and available only at specialized centers.

The RadOnk 130618 study is an observational study, meaning that data is collected and compared, but the treatment itself is not influenced by the study. The study investigates the use of proton therapy in patients with lymphomas in the chest cavity (mediastinum). The goal is to systematically document the frequency, feasibility, and side effects of this modern radiation therapy method. Particular attention is paid to sparing neighboring organs such as the heart, lungs, and breasts, as conventional radiation therapies can often lead to long-term complications in these areas. Proton therapy allows for more precise targeting of the tumor tissue, thereby better sparing healthy tissue. The study is prospective, meaning that patients are monitored over an extended period to assess the long-term effects of the treatment. The data collected is intended to help optimize future treatment recommendations and improve the quality of life for those affected. Patients will be regularly interviewed and medically monitored over a period of up to 100 months to gather long-term experience with the therapy. The study is purely observational; no treatment is provided as part of the study.

Eligible participants are women and men aged 18 and older with confirmed mediastinal lymphoma who are scheduled to receive proton therapy as first-line treatment.

Facts

  1. Disease: mediastinal lymphoma
  2. Cancer characteristics: histologically confirmed, indication for mediastinal radiation therapy
  3. What the study investigates: efficacy and side effects of proton therapy compared to the more commonly used photon therapy
  4. Study objective: To document the use of proton therapy in mediastinal lymphomas
  5. Study duration: Follow-up for up to 100 months
  6. Study characteristics: Observational only; no testing of a new therapy or medication; prospective; non-randomized

Trial sites

1 trial site in Germany is listed.

  • Nationales Centrum für Tumorerkrankungen Heidelberg

    Im Neuenheimer Feld 460, 69120 Heidelberg

    Recruiting

This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.

Medical editorial team

  • Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
  • PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine

This description is based on the public trial registry (NCT04613388) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.