The Second Affiliated Hospital of Hainan Medical University
Haikou, 570311, China
Location status: Recruiting
NCT Number: NCT06531681
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Haikou, 570311, China
Location status: Recruiting
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Radiation therapy with the MR-Linac
Time frame: 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.
Time frame: 3months, 6months,12months,24months,36months,60months
The time from the start of treatment until objective tumor Progression or patient all-cause death
Time frame: 3months, 6months,12months,24months,36months,60months
The percentage of patients whose cancer shrinks or remains stable over time
Time frame: 3months, 6months,12months,24months,36months,60months
Overall survival of participating patients will be obtained from the hospital information systems
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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%.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
junnv xu, doctor
CONTACT
yuecan zeng, doctor
CONTACT
The Second Affiliated Hospital of Hainan Medical University
Other
The Second Affiliated Hospital of Hainan Medical University
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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