Magnetic Resonance Guided Adaptive Stereotactic Body Radiotherapy for Lung Tumors in Ultracentral Location

MAGELLAN is a phase-I dose escalation trial that aims to identify the maximum tolerated dose (MTD) of MR-guided SBRT of ultracentral lung Tumors (primary objective). Thus, a maximum of 38 patients with ultracentral lung tumors (overlap of the planning target volume with the proximal bronchial tree and/or esophagus) will receive MR-guided SBRT including gated dose delivery and daily plan adaptation on a 0.35 MR-linac System. Dose levels are as follows: * 0 (de-escalation): 10 x 5.0Gy * 1 (start): 10 x 5.5Gy * 2: 10 x 6.0Gy * 3: 10 x 6.5Gy Dose escalation is performed according to a time-to-event continual reassessment method (TITE-CRM) with backup element. Patients are observed individually for 12 months to detect potential dose limiting toxicity (DLT = primary endpoint) and for a total of 24 months to detect potential tumor relapse.

NCT Number	NCT04925583
Lead Sponsor	University Hospital Heidelberg
Conditions	Lung Cancer
Enrollment	38 participants
Start Date	2021-11-01
Primary Completion	2030-11-01 (estimated)
Study Completion	2030-11-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-02