Actively Recruiting
Hypofractionated Stereotactic Radiotherapy for Treating Brain Oligometastases A Prospective Longitudinal Neurocognitive Study
Led by Chang Gung Memorial Hospital · Updated on 2023-05-01
135
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of hypofractionated stereotactic radiotherapy (HF-SRT) on patients newly diagnosed with brain oligometastases, which means having up to three brain metastatic lesions no larger than 4 cm. The study focuses on how this precise radiation treatment, which avoids the sensitive hippocampus area, impacts neurocognitive functions and cancer progression. This observational study aims to understand cognitive outcomes and brain tumor control while addressing concerns about conventional whole-brain radiation therapy's impact on memory and learning. The treatment involves delivering HF-SRT using volumetric-modulated arc therapy (VMAT) to target brain metastases while sparing the hippocampus. This radiotherapy is given over two weeks in five sessions, with a total dose between 3000 and 3500 cGy. Patients undergo baseline brain MRI and neurocognitive assessments before treatment. The study tracks cognitive function using seven standardized neuropsychological tests and monitors cancer progression and radiation side effects. Participants will have regular neurocognitive tests and brain imaging to assess treatment effects and cancer status for up to 24 months. The main outcome is cognitive-deterioration-free survival, measuring how long patients maintain stable neurocognitive function after treatment. Secondary outcomes include overall survival, patterns of brain cancer progression, and progression-free survival. Throughout the study, researchers will observe treatment safety, cognitive health, and tumor control in patients with good performance status.
CONDITIONS
Brief Title
A Neurocognitive Study in Patients With Brain Oligometastases Receiving Hypofractionated SRT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with pathologically-confirmed non-hematopoietic malignancy referred for postoperative or therapeutic hypofractionated stereotactic radiotherapy (HF-SRT)
- Fair or good performance status with ECOG score no worse than 2 or Karnofsky score at least 70
- No more than three brain metastatic lesions with greatest diameter no more than 4 cm on pre-radiotherapy MRI
You will not qualify if you...
- Primary cancer from hematological malignancies, germ cell tumors, or malignant meningiomas
- Brain metastasis within 5 mm of the hippocampus
- Metastasis involving the brain stem
- Clinical suspicion of leptomeningeal spreading
- Prior radiotherapy including stereotactic radiosurgery to brain/head region for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 2 weeks
Participants receive hypofractionated stereotactic radiotherapy (HF-SRT) delivered in 5 fractions within 2 weeks.
5 treatment visits (in-person)
Duration - Up to 24 months
Participants are monitored for neurocognitive outcomes and oncological endpoints up to 24 months after treatment.
Regular follow-up visits for assessments
Trial Site Locations
Total: 2 locations
1
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Actively Recruiting
2
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Actively Recruiting
Research Team
C
Chi-Cheng Chuang, M.D.
S
Shinn-Yn Lin, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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