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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorThe Second Affiliated Hospital of Hainan Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • MR-Linac

    Device

    Radiation therapy with the MR-Linac

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
3months, 6months,12months,24months,36months,60months

Secondary outcomes

1

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
2

Disease Control Rate

The percentage of patients whose cancer shrinks or remains stable over time

Time frame
3months, 6months,12months,24months,36months,60months
3

Overall survival

Overall survival of participating patients will be obtained from the hospital information systems

Time frame
3months, 6months,12months,24months,36months,60months
4

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

Other outcomes

Sponsors and contacts

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