RECRUITING

Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery

Conditions

Metastatic Malignant Neoplasm in the Brain Metastatic Malignant Solid Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-02-21

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03184038

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Wenyin Shi, MD

CONTACT

(215) 955-6702

wenyin.shi@jefferson.edu

Principal Investigator

Wenyin Shi, MD

PRINCIPAL_INVESTIGATOR

Sidney Kimmel Cancer Center at Thomas Jefferson University

Study Locations (Sites)

Jefferson Health New Jersey

Sewell, New Jersey, 08080

United States

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Wenyin Shi, MD, PRINCIPAL_INVESTIGATOR, Sidney Kimmel Cancer Center at Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-02-21

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2017-02-21

Study Completion Date2025-09-30

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Malignant Neoplasm in the Brain
Metastatic Malignant Solid Neoplasm