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 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
3,000
Radiation therapy with the MR-Linac
The Second Affiliated Hospital of Hainan Medical University
Haikou, China
RECRUITINGoverall 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.
Time frame: 3months, 6months,12months,24months,36months,60months
Progression-Free Survival
The time from the start of treatment until objective tumor Progression or patient all-cause death
Time frame: 3months, 6months,12months,24months,36months,60months
Disease Control Rate
The percentage of patients whose cancer shrinks or remains stable over time
Time frame: 3months, 6months,12months,24months,36months,60months
Overall survival
Overall survival of participating patients will be obtained from the hospital information systems
Time frame: 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
Time frame: 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.
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Time frame: 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.
Time frame: 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%.
Time frame: 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.
Time frame: During Radiotherapy