MR-guided radiation therapy for lung tumors near critical structures
Magnetic Resonance Guided Adaptive Stereotactic Body Radiotherapy for Lung Tumors in Ultracentral Location
PHASE1 · University Hospital Heidelberg · NCT04925583
This study is testing a new type of radiation therapy for patients with hard-to-treat lung tumors to see if it can safely deliver higher doses while protecting nearby organs.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Heidelberg (other) |
| Drugs / interventions | Bevacizumab, radiation |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT04925583 on ClinicalTrials.gov |
What this trial studies
The MAGELLAN trial is a phase I dose escalation trial designed to determine the maximum tolerated dose of magnetic resonance-guided stereotactic body radiotherapy (SBRT) for ultracentral lung tumors. A total of 38 patients will receive SBRT with daily plan adaptations and gated dose delivery to minimize radiation exposure to nearby sensitive organs. The trial will monitor patients for dose-limiting toxicity over 12 months and assess tumor control and patient outcomes over 24 months. This innovative approach aims to safely escalate radiation doses to improve treatment efficacy for challenging lung cancer cases.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with ultracentral lung tumors that are less than 5 cm in diameter and meet specific performance criteria.
Not a fit: Patients who have previously received radiation therapy to the lung or mediastinum that overlaps with the current target volumes may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could enable higher radiation doses for patients with ultracentral lung tumors, potentially improving treatment outcomes.
How similar studies have performed: While MR-guided SBRT is an emerging technique, similar studies have shown promise in improving treatment for lung tumors, though this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ultracentral location of the lung tumor, which is defined as an expected contact or overlap of the planning target volume with the proximal bronchial tree or esophagus at the time of consultation * indication for SBRT of the ultracentral pulmonary tumor * maximum diameter of the ultracentral pulmonary tumor \< 5cm * age \> 18 years of age * Karnofsky Performance Score \> 70% (ECOG Score 0 - 2) * ability to lie still on the MR-linac table for at least one hour * ability to hold one's breath for more than 20 seconds * successful completion of MRgRT simulation * for women with childbearing potential, adequate contraception. * ability of subject to understand character and individual consequences of the clinical trial * written informed consent (must be available before enrolment in the trial) Exclusion Criteria: * refusal of the patients to take part in the study * 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 * (planned) treatment with vascular endothelial growth factor (VEGF) inhibitors, e.g. Bevacizumab, within the time interval 2 weeks before and 2 weeks after SBRT * pregnant or lactating women * contraindications against performing MRI scans (pacemakers, other implants making MRI impossible) * participation in another competing clinical study or observation period of competing trials
Where this trial is running
Heidelberg
- University Hospital of Heidelberg, Radiation Oncology — Heidelberg, Germany (RECRUITING)
Study contacts
- Principal investigator: Juliane Hörner-Rieber, PD — University Hospital Heidelberg
- Study coordinator: Juliane Hörner-Rieber, PD
- Email: Juliane.Hoerner-Rieber@med.uni-heidelberg.de
- Phone: +49 6221-56
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.
Conditions: Lung Cancer, SBRT, IGRT, MR-guidance, ultracentral lung tumor, NSCLC, oligometastases