Precision Radiotherapy for Tumours Using Magnetic Resonance-guided Linear Accelerator (MR-Linac)
NCT ID: NCT06531681
Last Updated: 2025-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3000 participants
OBSERVATIONAL
2023-08-19
2028-12-31
Brief Summary
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Detailed Description
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· 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.)
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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MR-Linac
Radiation therapy with the MR-Linac
Eligibility Criteria
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Inclusion Criteria
* Age 18-75 years, male or female;
* ECOG score 0-2, life expectancy \> 6 months;
* Patients provide written informed consent.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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The Second Affiliated Hospital of Hainan Medical University
OTHER
Responsible Party
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Principal Investigators
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yuecan zeng, doctor
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of Hainan Medical University
Locations
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The Second Affiliated Hospital of Hainan Medical University
Haikou, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-K35-01
Identifier Type: -
Identifier Source: org_study_id
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