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

NCT04925583 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: RADONK-Magellan_2020
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Keywords

SBRT; IGRT; MR-guidance; ultracentral lung tumor; NSCLC; oligometastases

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity (DLT)

  Observation of the binary outcome dose-limiting toxicity (DLT). DLTs are defined in a catalogue of mainly pulmonary, esophageal and cardiac toxicity based on the CTCAE in Version 5.0.

  For 12 months from the beginning of SBRT.

Secondary Outcomes (18)

• Local tumor control

  For 24 months upon enrollment

• Regional tumor control

  For 24 months upon enrollment

• Distant tumor Control

  For 24 months upon enrollment

• Progression-free survival

  For 24 months upon enrollment

• Overall survival

  For 24 months upon enrollment

Study Arms (4)

Level 0

EXPERIMENTAL

Total dose 50 Gy, (10 x 5 Gy single dose)

Radiation: Stereotactic body radiotherapy (SBRT)

Level 1

EXPERIMENTAL

Total dose 55 Gy, (10 x 5.5 Gy single dose)

Radiation: Stereotactic body radiotherapy (SBRT)

Level 2

EXPERIMENTAL

Total dose 60 Gy, (10 x 6 Gy single dose)

Radiation: Stereotactic body radiotherapy (SBRT)

Level 3

EXPERIMENTAL

Total dose 65 Gy, (10 x 6.5 Gy single dose)

Radiation: Stereotactic body radiotherapy (SBRT)

Interventions

Stereotactic body radiotherapy (SBRT) RADIATION

* 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

Level 0; Level 1; Level 2; Level 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, 69120, Germany

Location

Related Publications (1)

• Regnery S, Ristau J, Weykamp F, Hoegen P, Sprengel SD, Paul KM, Buchele C, Kluter S, Rippke C, Renkamp CK, Pohl M, Meis J, Welzel T, Adeberg S, Koerber SA, Debus J, Horner-Rieber J. Magnetic resonance guided adaptive stereotactic body radiotherapy for lung tumors in ultracentral location: the MAGELLAN trial (ARO 2021-3). Radiat Oncol. 2022 May 25;17(1):102. doi: 10.1186/s13014-022-02070-x.

  PMID: 35614486 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Juliane Hörner-Rieber, PD

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Head

Model Details: Dose escalation, Arm 1: Level 0, 5.0 Gy, 10 fractions Arm 2: Level 1, 5.5 Gy, 10 fractions Arm 3: Level 2, 6.0 Gy, 10 fractions Arm 4: Level 3, 6.5 Gy, 10 fractoins

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: June 14, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)