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

The Second Affiliated Hospital of Hainan Medical University

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Radiation Toxicity; Oncology; Overall Response Rate
• Intervention / Treatment: Device: MR-Linac

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: junnv xu, doctor; Phone Number: 18208946196; Email: xujunnv@sina.com
• Study Contact Backup: Name: yuecan zeng, doctor; Phone Number: 19946610752; Email: wellyy2005@hainmc.edu.cn

Study Locations

• China
  • Haikou, China, 570311
    • Recruiting
    • The Second Affiliated Hospital of Hainan Medical University
    • Contact: junnv xu, doctor; Phone Number: 18208946196; Email: xujunnv@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The patients will receive or have completed imaging or treatment procedures at MR-Linac, Department of Radiotherapy, Second Affiliated Hospital of Hainan Medical University, age 18-75 years, male or female, ECOG score 0-2, life expectancy > 6 months.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall response rate	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.	3months， 6months，12months，24months，36months，60months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival	The time from the start of treatment until objective tumor Progression or patient all-cause death	3months， 6months，12months，24months，36months，60months
Disease Control Rate	The percentage of patients whose cancer shrinks or remains stable over time	3months， 6months，12months，24months，36months，60months
Overall survival	Overall survival of participating patients will be obtained from the hospital information systems	3months， 6months，12months，24months，36months，60months
Incidence of adverse reactions	Disease-specific toxicity is obtained from the hospital information system. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary	3months， 6months，12months，24months
Patient reported Health related quality of life (HRQoL)	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.	3months，6months，12months，24months
Dosimetric parameters：dose of target volume（TV）	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.	During Radiotherapy
Dosimetric parameters：OAR	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%.	During Radiotherapy
Dosimetric parameters：γ passing rate	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.	During Radiotherapy

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Hainan Medical University
• Investigators: Principal Investigator: yuecan zeng, doctor, The Second Affiliated Hospital of Hainan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024-K35-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No