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

Recruiting

• Conditions: C34; Malignant neoplasm of bronchus and lung

• Registration Number: DRKS00026665
• Lead Sponsor: Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

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

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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Loco-(regional) control rates<br>2. Recording cancer-specific, progression-free and overall survival

Secondary Outcome Measures

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