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ACTIVE NOT RECRUITING
NCT04925583
PHASE1

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

Sponsor: University Hospital Heidelberg

View on ClinicalTrials.gov

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

RADIATION

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