Clinical trial NCT06531681: Precision Radiotherapy for Tumours Using Magnetic Resonance-guided Linear Accelerator (MR-Linac)
Official title: The Second Affiliated Hospital of Hainan Medical University
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Overall Response Rate
Oncology
Radiation Toxicity
Quality of Life
Lead sponsor: The Second Affiliated Hospital of Hainan Medical University
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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: 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.)

Eligibility criteria: 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.

Primary outcomes:
measure: overall response rate
timeFrame: 3months， 6months，12months，24months，36months，60months
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: 3months， 6months，12months，24months，36months，60months
measure: Disease Control Rate
timeFrame: 3months， 6months，12months，24months，36months，60months
measure: Overall survival
timeFrame: 3months， 6months，12months，24months，36months，60months
measure: Incidence of adverse reactions
timeFrame: 3months， 6months，12months，24months
measure: Patient reported Health related quality of life (HRQoL)
timeFrame: 3months，6months，12months，24months
measure: Dosimetric parameters：dose of target volume（TV）
timeFrame: During Radiotherapy
measure: Dosimetric parameters：OAR
timeFrame: During Radiotherapy
measure: Dosimetric parameters：γ passing rate
timeFrame: During Radiotherapy
Other outcomes:
Locations:
city: Haikou
country: China
facility: The Second Affiliated Hospital of Hainan Medical University
Study officials:
affiliation: The Second Affiliated Hospital of Hainan Medical University
name: yuecan zeng, doctor
role: PRINCIPAL_INVESTIGATOR
References: