Precision Radiotherapy for Tumours Using Magnetic Resonance-guided Linear Accelerator (MR-Linac)

NCT ID: NCT06531681

Last Updated: 2025-02-13

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-19

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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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.)

Conditions

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Overall Response Rate Oncology Radiation Toxicity Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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MR-Linac

Radiation therapy with the MR-Linac

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients are undergoing or have undergone imaging or treatment at the MR linac;
* Age 18-75 years, male or female;
* ECOG score 0-2, life expectancy \> 6 months;
* Patients provide written informed consent.

Exclusion Criteria

* Contraindications to MRI, such as claustrophobia and metallic or electronic implants incompatible with MRI;
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Affiliated Hospital of Hainan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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junnv xu, doctor

Role: CONTACT

18208946196

yuecan zeng, doctor

Role: CONTACT

19946610752

Facility Contacts

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junnv xu, doctor

Role: primary

18208946196

Other Identifiers

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2024-K35-01

Identifier Type: -

Identifier Source: org_study_id

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