What this study is
This phase II trial studies the neurological function in patients with multiple brain metastases undergoing stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Assessment of neurocognitive function may help show that SRS preserves neurological function in patients with multiple brain metastases better than SBRT.
What's being tested
- Cognitive Assessment
Intervention · PROCEDURE
Undergo assessment of neurocognitive function
- Stereotactic Radiosurgery
Intervention · RADIATION
Undergo SRS
- Stereotactic Body Radiation Therapy
Intervention · RADIATION
Undergo SBRT
- Quality-of-Life Assessment
Intervention · OTHER
Ancillary studies
Study details
- Official title
- Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Conditions
- Metastatic Malignant Neoplasm in the Brain · Metastatic Malignant Solid Neoplasm
- Enrolling
- 90 people
- Starts
- 2017-02-21
- Est. completion
- 2026-09-30
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openJefferson Health New Jersey
Sewell, New Jersey, United States
- Karishma Kurowski, MPH · Contact856-341-5199karishma.kurowski@jefferson.edu
- Tamara LaCouture, MD · Principal investigator
Not yet recruitingSidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
- Wenyin Shi, MD · Contact(215) 955-6702
Recruiting
Study team
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Study ID 16D.651
Principal investigator
Wenyin Shi, MD
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.