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Magnetic Resonance Guided Adaptive Stereotactic Body Radiotherapy for Lung Tumors in Ultracentral Location
Sponsor: University Hospital Heidelberg
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
38
Start Date
2021-11-01
Completion Date
2030-11-01
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Stereotactic body radiotherapy (SBRT)
* level 0 (de-escalation): 10 x 5.0Gy * level 1 (start): 10 x 5.5Gy * level 2: 10 x 6.0Gy * level 3: 10 x 6.5Gy
Locations (1)
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany