C34
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| 1. Loco-(regional) control rates 2. Recording cancer-specific, progression-free and overall survival | — |
Secondary
| Measure | Time 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
Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LMU