Overall Response RateNCT06531681
Precision Radiotherapy for Tumours Using Magnetic Resonance-guided Linear Accelerator (MR-Linac)
An observational study of Overall Response Rate and Oncology, run by The Second Affiliated Hospital of Hainan Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overall Response Rate, Oncology, Radiation Toxicity
- What is being tested?
- MR-Linac
- Type of treatment
- Medical device
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 19 Aug 2023to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Hainan Medical University
Haikou, 570311
junnv xu, doctor, 18208946196, xujunnv@sina.com
About this study
Official title: The Second Affiliated Hospital of Hainan Medical University
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.
Read the 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.)
- Conditions
- Overall Response Rate, Oncology, Radiation Toxicity, Quality of Life
- Being tested
- MR-Linac
- Medical subject headings
- Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-LinacDevice
Radiation therapy with the MR-Linac
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3months， 6months，12months，24months，36months，60months
Secondary outcomes (8)
Progression-Free Survival
The time from the start of treatment until objective tumor Progression or patient all-cause death
Measured: 3months， 6months，12months，24months，36months，60months
Disease Control Rate
The percentage of patients whose cancer shrinks or remains stable over time
Measured: 3months， 6months，12months，24months，36months，60months
Overall survival
Overall survival of participating patients will be obtained from the hospital information systems
Measured: 3months， 6months，12months，24months，36months，60months
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
Measured: 3months， 6months，12months，24months
Patient reported Health related quality of life (HRQoL)
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.
Measured: 3months，6months，12months，24months
Dosimetric parameters：dose of target volume（TV）
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.
Measured: During Radiotherapy
Dosimetric parameters：OAR
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%.
Measured: During Radiotherapy
Dosimetric parameters：γ passing rate
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.
Measured: During Radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start19 Aug 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overall Response RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Hainan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yuecan zeng, doctor, Principal investigator, The Second Affiliated Hospital of Hainan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531681
- Sponsor's protocol ID
- 2024-K35-01
- Status last verified
- Feb 2025
- First submitted
- 28 Jun 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Second Affiliated Hospital of Hainan Medical University
- ClinicalTrials.gov ID
- NCT06531681
- Acronym / sponsor ID
- 2024-K35-01
- Conditions
- Overall Response Rate, Oncology, Radiation Toxicity, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Hainan Medical UniversityUniversity, hospital or other
- Study start
- 19 Aug 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-LinacRadiation therapy with the MR-Linac | Device | – |
Primary outcome
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.
8 secondary outcomes
Progression-Free Survival
Time frame: 3months， 6months，12months，24months，36months，60months
Disease Control Rate
Time frame: 3months， 6months，12months，24months，36months，60months
Overall survival
Time frame: 3months， 6months，12months，24months，36months，60months
Incidence of adverse reactions
Time frame: 3months， 6months，12months，24months
Patient reported Health related quality of life (HRQoL)
Time frame: 3months，6months，12months，24months
Dosimetric parameters：dose of target volume（TV）
Time frame: During Radiotherapy
Dosimetric parameters：OAR
Time frame: During Radiotherapy
Dosimetric parameters：γ passing rate
Time frame: During Radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
yuecan zeng, doctor principal investigator
The Second Affiliated Hospital of Hainan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overall Response Rate and Oncology, run by The Second Affiliated Hospital of Hainan Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact junnv xu, doctor (18208946196, xujunnv@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: 3months， 6months，12months，24months，36months，60months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.