Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study

Who is this study for? Patients with multiple brain metastases
What treatments are being studied? Cognitive Assessment+Stereotactic Radiosurgery+Stereotactic Body Radiation Therapy
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Procedure, Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New Jersey
Jefferson Health New Jersey
NOT_YET_RECRUITING
Sewell
Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
RECRUITING
Philadelphia
Contact Information
Primary
Wenyin Shi, MD
wenyin.shi@jefferson.edu
(215) 955-6702
Time Frame
Start Date: 2017-02-21
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 90
Treatments
Experimental: Supportive care (SRS/SBRT, neurocognitive testing)
Patients undergo SRS on day 1 or SBRT for 3 fractions over days 1-7 and undergo neurocognitive testing at baseline, 4, and 12 months after undergoing SRS or SBRT.
Related Therapeutic Areas
Sponsors
Leads: Sidney Kimmel Cancer Center at Thomas Jefferson University

This content was sourced from clinicaltrials.gov