Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531681
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-28
Brief Title:
Precision Radiotherapy for Tumours Using Magnetic Resonance-guided Linear Accelerator MR-Linac
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Second Affiliated Hospital of Hainan Medical University
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim to observe the application of MR-Linac for precision radiotherapy of tumours analyse its therapeutic effect toxic and side effectsCharacteristics 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-V30 was used and the higher the score the higher the quality of life
Dosimetric parameters include gross target volumeGTV clinical target volumeCTVinternal target volumeITVplanning target volumePTVγ-passing rateand limited dose of organs at risk including average dose maximum dose etc
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-V30 was used and the higher the score the higher the quality of life
Dosimetric parameters include gross target volumeGTV clinical target volumeCTVinternal target volumeITVplanning target volumePTVγ-passing rateand limited dose of organs at risk including average dose maximum dose etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None