Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06531681

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Hainan Medical University

Haikou, 570311, China

Location status: Recruiting

Location contact

junnv xu, doctor

CONTACT

[email protected]

18208946196

About this study

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.)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MR-Linac

Device

Radiation therapy with the MR-Linac

Primary outcomes

  1. overall response rate

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

    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.

Secondary outcomes

  1. Progression-Free Survival

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

    The time from the start of treatment until objective tumor Progression or patient all-cause death

  2. Disease Control Rate

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

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

  3. Overall survival

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

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

  4. Incidence of adverse reactions

    Time frame: 3months, 6months,12months,24months

    Disease-specific toxicity is obtained from the hospital information system. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary

  5. Patient reported Health related quality of life (HRQoL)

    Time frame: 3months,6months,12months,24months

    Patient reported health related quality of life is captured through a questionnaire the Generic European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30. It is a core scale applicable to all cancer patients. It contains a total of 30 items, items 1 to 28 are divided into 4 grades and scored 1 to 4 points, items 29 and 30 are divided into 7 grades and scored 1 to 7 points. The 30 entries are divided into 15 domains, including 5 functional domains (i.e., somatic, role, cognitive, emotional, and social), 3 symptom domains (i.e., fatigue, pain, nausea, and vomiting), 1 quality of life domain, and 6 single entries/domains. A high score on functional or global health status scale represents a high/healthy level of functioning.

  6. Dosimetric parameters:dose of target volume(TV)

    Time frame: During Radiotherapy

    Dose of target volume(TV)includes gross target volume(GTV),clinical target volume(CTV),internal target volume(ITV) and planning target volume(PTV),Measured by cGy.

  7. Dosimetric parameters:OAR

    Time frame: During Radiotherapy

    Limited dose of organ at risk(OAR) ,includes mean dose(Dmean), maximum dose(Dmax)and minimum dose(Dmin),Measured by cGy.

    Volume dose limitation,Measured by percent(%),for example, lung V20≤30%.

  8. Dosimetric parameters:γ passing rate

    Time frame: During Radiotherapy

    The gamma passing rate evaluates the coincidence between the calculated and measured dose distributions by utilizing the percent dose difference (DD) and distance to agreement.

Study contacts

Contact information is provided by the study sponsor or research team.

junnv xu, doctor

CONTACT

[email protected]

18208946196

yuecan zeng, doctor

CONTACT

[email protected]

19946610752

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Hainan Medical University

Other

Registry information

Official study title

The Second Affiliated Hospital of Hainan Medical University

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Aug 1, 2024
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.