Magnetic Resonance Imaging-guided Adaptive Radiotherapy for Large Brain Metastases

Brain Metastases Clinical Trial

Official title:

Displacement and Deformation Analysis of Adaptive Radiotherapy Based on MR-Linac for Large Brain Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06405256
• Other study ID #: BMMRIgART
• Status: Recruiting
• Start date: January 3, 2020
• Est. completion date: March 18, 2025

Study information

• Verified date: March 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Nan Bi, MD
• Phone: 8601087788799
• Email: binan_email[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 18, 2025
• Est. primary completion date: March 18, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Radiation:
• magnetic resonance imaging-guided adaptive radiotherapy
Stereotactic Radiotherapy (with the prescribed dose of PTV 52-52.5 Gy, 13-15 fractions and Boost (if any) 60Gy, 15 fractions)

Locations

Country	Name	City	State
China	Chinese Academy of Medical Science and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-cranial progression-free survival (IPFS)	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.	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.
Secondary	Local control rate (LCR)	LCR will be calculated as the number of patients without intrathoracic tumor progression per RECIST Criteria.	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.
Secondary	Overall survival (OS)	Defined as the time from the date of radiation to the date of any documented death due to any cause.	From the date of radiation until the date of any documented death due to any cause,, assessed up to 12 months.
Secondary	Objective Response Rate (ORR)	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.	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.
Secondary	Disease control rate (DCR)	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.	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.
Secondary	Adverse Event	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.	AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of radiation, up to 12 months.