NCT05163509

MR-linac Guided Adaptive Radiotherapy for Inoperable Mediastinal Tumor

A Prospective, Phase II Study of MR-Linac Guided Adaptive Radiotherapy for Inoperable Mediastinal Tumor

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This Phase II study is to determine the efficacy and safety of MR-Linac Guided Radiotherapy in patients with inoperable mediastinal tumors.

Detailed description

This Phase II study is to determine the efficacy and safety of MR-Linac Guided Radiotherapy in patients with inoperable mediastinal tumors. Patients will receive radiotherapy on the MR-Linac treatment machine. The primary end point is 2-year local-recurrence free survival. The secondary end points are objective response rate, 2-y PFS, 2-y OS, safety of treatment, dose coverage of targets and dose to normal organs.

Conditions

• Mediastinal Tumor

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Unity-based MR-Linac guided Radiotherapy	The radiotherapy was delivered using the Unity-based MR-Linac treatment machine.

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2021-12-20
• Last updated: 2021-12-20

Locations

1 site across 1 country: China