Evaluating brain function in patients with multiple brain tumors treated with targeted radiation
Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study
NA · Thomas Jefferson University · NCT03184038
This study is testing whether a specific type of radiation treatment for multiple brain tumors helps patients keep their thinking skills and quality of life better than another type of radiation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Sewell, New Jersey and 1 other locations) |
| Trial ID | NCT03184038 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the neurocognitive function of patients with multiple brain metastases who are treated with either stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). The study aims to determine if SRS can better preserve neurological function compared to SBRT by assessing cognitive performance at 4 and 12 months post-treatment. Participants will undergo a series of neurocognitive tests and quality of life assessments, alongside monitoring for symptom burden and survival outcomes. The trial includes a follow-up period to evaluate the long-term effects of the treatments on brain function and overall health.
Who should consider this trial
Good fit: Ideal candidates include patients with pathologically proven solid tumor malignancies and 1 to 10 brain metastases who are in good general health.
Not a fit: Patients with small cell lung cancer or those with significant comorbidities that prevent participation in cognitive assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies that better preserve cognitive function in patients with brain metastases.
How similar studies have performed: Other studies have shown promising results with stereotactic radiosurgery in preserving cognitive function, making this approach a potentially viable option.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically proven solid tumor malignancy (except for small cell lung cancer \[SCLC\], germ cell tumor) * Karnofsky performance status \>= 60 * 1 to 10 brain metastases (mets) (no more than two lesions and/or cavities \>= 3 cm in maximum diameter) * Maximum diameter of brain metastasis or resection cavity is 6 cm * Serum creatinine =\< 3 mg/dL and creatinine clearance \>= 30 ml/min * Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up; patients must be willing to complete neurocognitive assessments at pre-specified time points outlined in the protocol * Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 21 days prior to registration * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 4 months after last dose * Patient able to provide his/her own written informed consent and speak English Exclusion Criteria: * Patient with diagnosis of glioma, or other World Health Organization (WHO) grade II - IV primary brain tumor * Prior brain surgery =\< 14 days prior to enrollment * Planned chemotherapy during radiosurgery * Leptomeningeal metastases * Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per week for the past 2 months * Pregnant women
Where this trial is running
Sewell, New Jersey and 1 other locations
- Jefferson Health New Jersey — Sewell, New Jersey, United States (NOT_YET_RECRUITING)
- Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Wenyin Shi, MD — Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Study coordinator: Wenyin Shi, MD
- Email: wenyin.shi@jefferson.edu
- Phone: (215) 955-6702
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.
Conditions: Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm