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Trial Title:
Precision Radiotherapy for Tumours Using Magnetic Resonance-guided Linear Accelerator (MR-Linac)
NCT ID:
NCT06531681
Condition:
Overall Response Rate
Oncology
Radiation Toxicity
Quality of Life
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
MR-Linac
Description:
Radiation therapy with the MR-Linac
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.)
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of Hainan Medical University
Address:
City:
Haikou
Zip:
570311
Country:
China
Status:
Recruiting
Contact:
Last name:
junnv xu, doctor
Phone:
18208946196
Email:
xujunnv@sina.com
Start date:
August 19, 2023
Completion date:
December 31, 2028
Lead sponsor:
Agency:
The Second Affiliated Hospital of Hainan Medical University
Agency class:
Other
Source:
The Second Affiliated Hospital of Hainan Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06531681
