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

Hainan Medical University

Status: Enrolling

Conditions: Oncology; Radiation Toxicity; Quality of Life; Overall Response Rate

Treatments: Device: MR-Linac

Study type: Observational

Funder types: Other

Identifiers

NCT06531681

2024-K35-01

Details and patient eligibility

About

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.

Full 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.)

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients are undergoing or have undergone imaging or treatment at the MR linac;
• Age 18-75 years, male or female;
• ECOG score 0-2, life expectancy > 6 months;
• Patients provide written informed consent.

Exclusion criteria

• Contraindications to MRI, such as claustrophobia and metallic or electronic implants incompatible with MRI;
• The presence of severe comorbidities that, in the opinion of the investigator, · preclude the toleration or completion of radiotherapy;
• Acute inflammatory disease requiring systemic therapy;
• The presence of active infectious disease;
• Pregnant women, nursing mothers, and patients planning to have children during the study period.