Precision Radiotherapy for Tumours Using Magnetic Resonance-guided Linear Accelerator (MR-Linac)
NCT Number: NCT06531681
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Overall Response Rate|Oncology|Radiation Toxicity|Quality of Life
Interventions: DEVICE: MR-Linac
Sponsor: The Second Affiliated Hospital of Hainan Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-19
Completion Date: 2028-12-31
Locations: The Second Affiliated Hospital of Hainan Medical University, Haikou, 570311, China

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.

Primary Outcome Measures: 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: 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