NCT06531681

Precision Radiotherapy for Tumours Using Magnetic Resonance-guided Linear Accelerator (MR-Linac)

The Second Affiliated Hospital of Hainan Medical University

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: The Second Affiliated Hospital of Hainan Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Aim to observe the application of MR-Linac for precision radiotherapy of tumours, analyse its therapeutic effect, toxic and side effects,Characteristics of dosimetric parameters etc.

Detailed description

Primary endpoint: · Overall response rate (ORR) : It refers to the proportion of patients whose tumor volume reduction reaches the pre-specified value and can maintain the minimum time requirement, which is a Complete Response (CR) and a partial response (PR). Partial Response) sum of the proportions. Secondary points: * Progression-free Survival (PFS) : the time from the start of treatment until objective tumor Progression or all-cause death of the patient. * Disease Control Rate (DCR) : The percentage of patients whose cancer shrinks or remains stable over time. * Overall Survival (OS) : the time from the start of treatment to all-cause death. * Incidence of adverse reactions: toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE). * Quality of life: The EORTC Quality of Life measure -QLQ-C30-(V3.0) was used, and the higher the score, the higher the quality of life. * Dosimetric parameters： include gross target volume（GTV）， clinical target volume（CTV），internal target volume(ITV),planning target volume（PTV），γ-passing rate，and limited dose of organs at risk (including average dose, maximum dose, etc.)

Conditions

• Overall Response Rate
• Oncology
• Radiation Toxicity
• Quality of Life

Interventions

Type	Name	Description
DEVICE	MR-Linac	Radiation therapy with the MR-Linac

Timeline

• Start date: 2023-08-19
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2024-08-01
• Last updated: 2025-02-13

Locations

1 site across 1 country: China