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Clinical Trials/DRKS00026665
DRKS00026665
Recruiting
Not Applicable

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

Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LM0 sites10 target enrollmentNovember 8, 2021
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ConditionsC34Malignant neoplasm of bronchus and lung

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
C34
Sponsor
Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LM
Enrollment
10
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 8, 2021
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinikum Grosshadern der LM

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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