MR-guided adaptive radiotherapy for advanced lung cancer
Pulmonary Magnetic Resonance-guided Online Adaptive Radiotherapy of Locally Advanced Non-Small Cell Lung Cancer
This study is testing a new way of giving radiation therapy for advanced lung cancer that adjusts treatment based on real-time changes in the tumor to see if it helps patients feel better and have fewer side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Heidelberg Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 3 sites (Tübingen, Baden-Württemberg and 2 other locations) |
| Trial ID | NCT05237453 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of magnetic resonance-guided online adaptive radiotherapy (ART) for patients with locally advanced non-small cell lung cancer (LA-NSCLC). The study aims to demonstrate the feasibility of this innovative technique, which allows for personalized treatment by adapting radiation delivery based on real-time changes in tumor geometry and surrounding organs at risk. By optimizing the balance between effective tumor targeting and minimizing toxicity, the trial seeks to improve local tumor control and patient outcomes. The findings will inform the design of a subsequent phase I/II study comparing MR-guided ART to traditional CT-based approaches.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically-proven stage III A-C non-small cell lung cancer who are eligible for definitive thoracic chemoradiotherapy.
Not a fit: Patients with involvement of supraclavicular lymph nodes or additional pulmonary lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and reduced side effects for patients with locally advanced lung cancer.
How similar studies have performed: While MR-guided radiotherapy is a relatively novel approach, preliminary studies have shown promising results in improving treatment precision and patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Tübingen, Baden-Württemberg and 2 other locations
- Universitätsklinikum Tübingen — Tübingen, Baden-Württemberg, Germany (Recruiting)
- Ludwig-Maximilian-Universität München — Münich, Bayern, Germany (Recruiting)
- University Hospital of Heidelberg, Radiation Oncology — Heidelberg, Germany (Recruiting)
Study contacts
- Principal investigator: Juergen Debus, Prof — University Hospital Heidelberg
- Study coordinator: Sebastian Regnery, MD
- Email: sebastian.regnery@med.uni-heidelberg.de
- Phone: +496221 56
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.