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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR-Linac | Device | Radiation therapy with the MR-Linac |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| junnv xu, doctor | Contact | 18208946196 | xujunnv@sina.com | |
| yuecan zeng, doctor | Contact | 19946610752 | wellyy2005@hainmc.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| yuecan zeng, doctor | The Second Affiliated Hospital of Hainan Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Hainan Medical University | Recruiting | Haikou | 570311 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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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 |