Status:
RECRUITING
Pulmonary Magnetic Resonance-guided Online Adaptive Radiotherapy of Locally Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
University Hospital Heidelberg
Collaborating Sponsors:
University Hospital Tuebingen
Ludwig-Maximilians - University of Munich
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
MR-guided radiotherapy is an innovative technique which supports sophisticated approaches towards pulmonary adaptive radiotherapy (ART). Such individualized treatment approaches can lead to reduced to...
Detailed Description
Non-small cell lung cancer (NSCLC) is very common and carries the highest mortality of all malignant diseases (350.000 - 400.000 deaths per year in the European Union). In specific, the 5-year overall...
Eligibility Criteria
Inclusion
- Histologically-proven non-small cell lung cancer (NSCLC)
- Stage III A - C according to the 8th edition of the Union for International Cancer Control (UICC) TNM classification
- Indication for definitive thoracic chemoradiotherapy
- Age ≥ 18 years
- ECOG 0 - 2
- Adequate pulmonary function for chemoradiotherapy confirmed by a current pulmonary function test (≤ 6 weeks from treatment start)
- Ability to lie still on the MR-linac table for at least one hour
- Ability to hold one's breath for at least 20 seconds
- Successful completion of an MR-guided treatment simulation
- For women with childbearing potential: adequate contraception
- Ability of the patient to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrolment in the trial)
Exclusion
- Involvement of supraclavicular lymph nodes (supraclavicular N3)
- Additional pulmonary lesions (T3 - 4 due to additional lesion in the same or another lobe)
- Previous radiotherapy of the lung and mediastinum, if previous and current target volumes overlap
- Patients who have not yet recovered from acute toxicities of prior therapies
- Contraindications against performing MRI scans (e.g. pacemakers or other implants making MRI impossible)
- Pregnant or lactating women
- Participation in another competing clinical study or observation period of competing trials
- Refusal of the patients to take part in the study
Key Trial Info
Start Date :
June 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05237453
Start Date
June 23 2022
End Date
March 1 2027
Last Update
January 5 2024
Active Locations (3)
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1
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany, 72076
2
Ludwig-Maximilian-Universität München
Münich, Bavaria, Germany, 81377
3
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany, 69120