Magnetic Resonance Imaging-guided Adaptive Radiotherapy for Large Brain Metastases

Recruiting

• Conditions: Brain Metastases
• Interventions: Radiation: magnetic resonance imaging-guided adaptive radiotherapy

• Registration Number: NCT06405256
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

This study is an ambispective cohort study to evaluate the displacement and deformation of large brain metastases (BM) treated with magnetic resonance imaging-guided adaptive radiotherapy (MRIgART)

Detailed Description

All patients had a pathologically confirmed malignant cancer and were diagnosed with brain metastases (BM) by enhanced magnetic resonance imaging (MRI) with BM volume of 2cm and above. All patients received Unity MR-linac adaptive radiotherapy. Gross tumor volume (GTV) and organs at risk (OARs) were re-delineated for every image set and analyzed for displacement and deformation.

Study Timeline

• Study Start: 2020-01-03
• Status Verified: 2024-03
• Study First Submitted: 2024-05-04
• Study First Submitted QC: 2024-05-04
• Last Update Submitted: 2024-05-04
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-03-18
• Study Completion: 2025-03-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age ≥ 18 years; KPS score ≥ 60.
2. pathologically confirmed lung cancer.
3. diagnosed with brain metastases by enhanced MRI.
4. BM volume ≥ 2cm.
5. Anticipated time to survival>3 months.
6. Treated with Unity MR-linac.
7. Good compliance; Able to stay still in supine position for 45 minutes and above.

Exclusion Criteria

1. Fail to complete radiotherapy as planned; Anticipated time to survival less than 3 months.
2. Suffer from severe back pain in supine position, unable to receive Unity MR-linac.
3. Suffer from severe claustrophobia.
4. Incomplete pre-Unity image data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BM patients receiving MRIgART	magnetic resonance imaging-guided adaptive radiotherapy	For it's an observational study, all patients eligible will be divided into the group "BM patients receiving MRIgART"

Primary Outcome Measures

Name	Time	Method
Intra-cranial progression-free survival (IPFS)	From the date of radiation until the date of first documented intracalcarine recurrence or progression, or date of death from any cause, whichever came first, assessed up to 12 months.	Defined as the time from date of radiation until the date of first documented intracalcarine recurrence or progression, or date of death from any cause, whichever came first.

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR)	Tumor assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 12 months.	DCR will be calculated as the number of patients with CR, PR or sustained SD≥6 weeks per RECIST Criteria.; Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase.
Local control rate (LCR)	Tumor assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 12 months.	LCR will be calculated as the number of patients without intrathoracic tumor progression per RECIST Criteria.
Overall survival (OS)	From the date of radiation until the date of any documented death due to any cause,, assessed up to 12 months.	Defined as the time from the date of radiation to the date of any documented death due to any cause.
Objective Response Rate (ORR)	Tumor assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 12 months.	The objective response rate (ORR) will be calculated as the number of patients with CR or PR per RECIST Criteria.; Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Adverse Event	AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of radiation, up to 12 months.	The incidence of adverse events (AEs) and serious adverse events (SAEs) is evaluated by EORTC/RTOG Radiation Grading System Criteria and CTCAE 5.0. Appropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse event will be calculated.

Trial Locations

Locations (1)

Chinese Academy of Medical Science and Peking Union Medical College; 🇨🇳 Beijing, China