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Prospective evaluation of the safety and efficacy of MR-guided moderately hypofractionated radiotherapy for inoperable malignant tumors of the lung, pleura, and mediastinum with a diameter > 5 cm and poor risk factors - MR-HYPOLUNG

Prospective evaluation of the safety and efficacy of MR-guided moderately hypofractionated radiotherapy for inoperable malignant tumors of the lung, pleura, and mediastinum with a diameter > 5 cm and poor risk factors - MR-HYPOLUNG - MR-HYPOLUNG

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00026665
Enrollment
10
Registered
2021-11-08
Start date
2020-12-14
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C34

Interventions

Group 1: Single-center observational study of patients with unresectable malignant tumors of the lung, pleura, and mediastinum with a diameter > 5cm and poor risk factors who will receive MR-guided ra

Sponsors

Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LMU
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed, inoperable tumor of the lung, pleura or mediastinum with a diameter > 5 cm. 2. Age = 18 years 3. Limited pulmonary function and reserve (FEV = 1L and/or DLCO <40% or long-term oxygen therapy). 4. ECOG Performance Status = 2 5. Prior surgery, systemic and local ablative therapies (RFA, SABR, brachytherapy, etc.) are allowed. 6. Indication for radiotherapy confirmed at the multidisciplinary tumor board. 7. Patients are able to understand and willing to sign an IRB-approved informed consent document and adhere to the conditions of the study

Exclusion criteria

Exclusion criteria: 1. Known contraindications for radiotherapy e.g. severe comorbidities, interstitial lung disease etc. 2. Significant overlap with a previously treated radiation volume - prior radiotherapy is generally allowed as long as all dose requirements are met in the composite plan (biologically effective doses are calculated for this purpose). 3. Pregnant and/or breastfeeding. 4. Medical or psychological impairments that do not allow proper informed consent or trial participation. 5. Lack of legal capacity.

Design outcomes

Primary

MeasureTime frame
1. Loco-(regional) control rates 2. Recording cancer-specific, progression-free and overall survival

Secondary

MeasureTime frame
1. Prospective documentation of longitudinal changes inpulmonary function parameters (especially FEV1 and DLCO) after online MRgRT as part of the scheduled follow-up. 2. Recording of acute toxicity according to standardized recording forms. 3. Recording of pulmonary events (exacerbation of COPD, pulmonary fibrosis) during follow-up.

Countries

Germany

Contacts

Public ContactChukwuka Eze

Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LMU

Chukwuka.Eze@med.uni-muenchen.de+4989440073770

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026