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Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03184038
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sidney Kimmel Cancer Center at Thomas Jefferson University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Wenyin Shi, MD
Principal Investigator Affiliation Sidney Kimmel Cancer Center at Thomas Jefferson University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm
Study Website: View Trial Website
Additional Details

PRIMARY OBJECTIVES:

  • I. Assessment of neurocognitive function at months 4.
SECONDARY OBJECTIVES:
  • I. Assessment of neurocognitive function at months 4 and 12 as measured by neurocognitive decline on a battery of tests.
  • II. Assessment of symptom burden, as measured by the M.
D. Anderson Symptom Inventory- Brain Tumor Module (MDASI-BT).
  • III. Assessment of quality adjusted survival and health outcomes using the European Quality of Life Five Dimension Five Level scale questionnaire (EQ-5D-5L).
  • IV. Assessment of local control, in brain control.
  • V. Assessment of progression free survival (PFS), and overall survival (OS).
  • VI. Assessment of side effects and toxicities.
OUTLINE: 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. After completion of study, patients are followed up at 2, 4, 6, 8, 10, and 12 months.

Arms & Interventions

Arms

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.

Interventions

Procedure: - Cognitive Assessment

Undergo assessment of neurocognitive function

Radiation: - Stereotactic Radiosurgery

Undergo SRS

Radiation: - Stereotactic Body Radiation Therapy

Undergo SBRT

Other: - Quality-of-Life Assessment

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Philadelphia, Pennsylvania

Status

Recruiting

Address

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

Site Contact

Wenyin Shi, MD

[email protected]

215-955-6702

Aria Health, Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

Aria Health

Philadelphia, Pennsylvania, 19118

Site Contact

Shari Rudoler, MD

[email protected]

215-612-4300

Reading Hospital, Reading, Pennsylvania

Status

Recruiting

Address

Reading Hospital

Reading, Pennsylvania, 19601

Site Contact

Terrence Cescon, MD

[email protected]

484-628-0900