NCT03184038 Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
| NCT ID | NCT03184038 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University |
| Condition | Metastatic Malignant Neoplasm in the Brain |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2017-02-21 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2017-02-21 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Wenyin Shi, MD
PRINCIPAL INVESTIGATOR
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Frequently Asked Questions
Who can join the NCT03184038 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Malignant Neoplasm in the Brain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03184038 currently recruiting?
Yes, NCT03184038 is actively recruiting participants. Contact the research team at wenyin.shi@jefferson.edu for enrollment information.
Where is the NCT03184038 trial being conducted?
This trial is being conducted at Sewell, United States, Philadelphia, United States.
Who is sponsoring the NCT03184038 clinical trial?
NCT03184038 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The principal investigator is Wenyin Shi, MD at Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The trial plans to enroll 90 participants.