Clinical trial NCT06405256: Magnetic Resonance Imaging-guided Adaptive Radiotherapy for Large Brain Metastases
Official title: Displacement and Deformation Analysis of Adaptive Radiotherapy Based on MR-Linac for Large Brain Metastases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Metastases
Keywords: Magnetic Resonance Imaging-guided Adaptive Radiotherapy
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intra-cranial progression-free survival (IPFS)
timeFrame: 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 outcomes:
measure: Local control rate (LCR)
timeFrame: 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.
measure: Overall survival (OS)
timeFrame: From the date of radiation until the date of any documented death due to any cause,, assessed up to 12 months.
measure: Objective Response Rate (ORR)
timeFrame: 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.
measure: Disease control rate (DCR)
timeFrame: 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.
measure: Adverse Event
timeFrame: AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of radiation, up to 12 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Science and Peking Union Medical College
Study officials:
affiliation: Chinese Academy of Medical Sciences and Peking Union Medical College
name: Nan Bi, MD
role: PRINCIPAL_INVESTIGATOR
References: