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

Recruiting

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

• Registration Number: NCT06531681
• Lead Sponsor: The Second Affiliated Hospital of Hainan Medical University

Brief 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.)

Study Timeline

• Study Start: 2023-08-19
• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-07-29
• Study First Posted: 2024-08-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall response rate	3months， 6months，12months，24months，36months，60months	The proportion of patients whose tumor volume reduction reached the predetermined value and maintained the minimum time limit requirement was the sum of CR (Complete Response) and PR (Partial Response) proportions.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival	3months， 6months，12months，24months，36months，60months	The time from the start of treatment until objective tumor Progression or patient all-cause death
Incidence of adverse reactions	3months， 6months，12months，24months	Disease-specific toxicity is obtained from the hospital information system. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary
Dosimetric parameters：dose of target volume（TV）	During Radiotherapy	Dose of target volume（TV）includes gross target volume（GTV），clinical target volume（CTV），internal target volume(ITV) and planning target volume（PTV）,Measured by cGy.
Disease Control Rate	3months， 6months，12months，24months，36months，60months	The percentage of patients whose cancer shrinks or remains stable over time
Dosimetric parameters：γ passing rate	During Radiotherapy	The gamma passing rate evaluates the coincidence between the calculated and measured dose distributions by utilizing the percent dose difference (DD) and distance to agreement.
Dosimetric parameters：OAR	During Radiotherapy	Limited dose of organ at risk（OAR） ，includes mean dose（Dmean）, maximum dose（Dmax）and minimum dose（Dmin），Measured by cGy.; Volume dose limitation，Measured by percent（%），for example， lung V20≤30%.
Patient reported Health related quality of life (HRQoL)	3months，6months，12months，24months	Patient reported health related quality of life is captured through a questionnaire the Generic European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30. It is a core scale applicable to all cancer patients. It contains a total of 30 items, items 1 to 28 are divided into 4 grades and scored 1 to 4 points, items 29 and 30 are divided into 7 grades and scored 1 to 7 points. The 30 entries are divided into 15 domains, including 5 functional domains (i.e., somatic, role, cognitive, emotional, and social), 3 symptom domains (i.e., fatigue, pain, nausea, and vomiting), 1 quality of life domain, and 6 single entries/domains. A high score on functional or global health status scale represents a high/healthy level of functioning.
Overall survival	3months， 6months，12months，24months，36months，60months	Overall survival of participating patients will be obtained from the hospital information systems

Trial Locations

Locations (1)

The Second Affiliated Hospital of Hainan Medical University; 🇨🇳 Haikou, China