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New treatment option for Metastatic Malignant Neoplasm in the Brain
Official title Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
ClinicalTrials.gov ID: NCT03184038
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 =\ = 30 ml/min
You likely 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
See the full eligibility 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 =\ = 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Sewell, New Jersey, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sewell, New Jersey, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.