Neurocognitive assessment in patients with brain oligometastases receiving targeted radiotherapy
Hypofractionated Stereotactic Radiotherapy for Treating Brain Oligometastases - A Prospective Longitudinal Neurocognitive Study
This study is testing if a new type of targeted radiation therapy can help people with brain oligometastases keep their thinking skills better than the usual whole-brain radiation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 135 (estimated) |
| Ages | 18 Years to 84 Years |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Taoyuan and 1 other locations) |
| Trial ID | NCT04805255 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients diagnosed with brain oligometastases who are receiving hypofractionated stereotactic radiotherapy (HF-SRT). The aim is to evaluate the neurocognitive functions of these patients, particularly in relation to the potential cognitive decline associated with conventional whole-brain radiation therapy. By utilizing HF-SRT, the study seeks to mitigate the adverse effects on cognitive health that can arise from traditional treatment methods. Participants will be monitored for their cognitive performance following treatment to assess the effectiveness of this approach.
Who should consider this trial
Good fit: Ideal candidates include adults with a confirmed non-hematopoietic malignancy and up to three brain metastases, each no larger than 4 cm.
Not a fit: Patients with hematological malignancies, certain types of brain tumors, or those with metastases near critical brain structures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive outcomes for patients undergoing treatment for brain oligometastases.
How similar studies have performed: Previous studies have shown promising results with hypofractionated stereotactic radiotherapy in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with pathologically-confirmed non-hematopoietic malignancy who are referred for postoperative adjuvant or therapeutic hypofractionated stereotactic radiotherapy (HF-SRT). * A Fair/good performance status no worse than Eastern Cooperative Group (ECOG) of 2 or an acceptable performance status of Karnofsky Score (KPS) at least 70. * The number and extent of brain metastatic lesions should be no more than three metastatic foci with a greatest diameter no more than 4 cm shown on pre-radiotherapy MRI; namely, that is the clinical setting of oligometastatic brain disease or brain oligometastases. Exclusion Criteria: * Patients with their primary cancer arising from hematological malignancies (i.e., malignant lymphomas, leukemia), germ cell tumors, or malignant meningiomas * Patients with MRI-identified metastasis within 5 mm peri-hippocampally * Patients with metastasis involving the brain stem * Clinical suspicion of leptomeningeal spreading * History of prior radiotherapy including stereotactic radiosurgery delivered to brain/head region for any reasons
Where this trial is running
Taoyuan and 1 other locations
- Chang Gung Memorial Hospital — Taoyuan, Taiwan (Recruiting)
- Chang Gung Memorial Hospital — Taoyuan, Taiwan (Recruiting)
Study contacts
- Study coordinator: Chi-Cheng Chuang, M.D.
- Email: ccc2915@cgmh.org.tw
- Phone: +886-33281200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.