RECRUITING

NTS-WBRT in Brain Metastases

Conditions

Quick Navigation

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 research is being done to assess the quality of life and symptom burden in participants who receive (normal tissue sparing whole brain radiation therapy (NTS-WBRT). This research study involves: * NTS-WBRT (normal tissue sparing whole brain radiation therapy) * Memantine standard of care drug

Official Title

Phase II Trial of Normal Tissue Sparing Whole Brain Radiation Therapy (NTS-WBRT) in Patients With Brain Metastases

Quick Facts

Study Start:2022-02-08

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05013892

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
* Any patient with a solid tumor diagnosis and any number of brain metastasis clinically indicated for cranial irradiation with whole brain radiation therapy * Age ≥ 18 * Karnofsky Performance Status ≥ 70 * Prior stereotactic radiosurgery (SRS) permissible per physician discretion * Prior craniotomy permissible per physician discretion. Protocol radiation therapy should be initiated ≥2 weeks after craniotomy. * Prior partial brain radiation therapy permissible if target volume \< 50% brain and per physician discretion * Expectant \> 6 months survival * Ability to understand and the willingness to sign a written informed consent document. * Fluency in English, able to complete questionnaires and neurocognitive testing * Ability to undergo MRI with gadolinium examination * Ability to return for follow-up examinations throughout the course of this study for a maximum of 2 years after radiation treatment completion * Any prior, concomitant, or post-radiotherapy systemic therapy is permitted at discretion of treating physicians * Negative pregnancy test for premenopausal women	* Leptomeningeal disease (by any one or more of clinical assessment, radiographic assessment, or cerebrospinal fluid study) * Prior whole brain radiation therapy * Pre-existing or current use of memantine or other NMDA antagonists * Known allergy to contrast used in imaging studies and/or inability to have MRI imaging * Uncontrolled intercurrent illness that could significantly affect baseline cognitive function as determined by the enrolling clinician, such as symptomatic congestive heart failure, unstable angina pectoris, prior CVA, significant uncontrolled epilepsy or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or unwilling to use appropriate contraception to prevent pregnancy during the time of radiation therapy * Concurrent participation in an investigational systemic therapy protocol.

Inclusion Criteria

Exclusion Criteria

* Any patient with a solid tumor diagnosis and any number of brain metastasis clinically indicated for cranial irradiation with whole brain radiation therapy
* Age ≥ 18
* Karnofsky Performance Status ≥ 70
* Prior stereotactic radiosurgery (SRS) permissible per physician discretion
* Prior craniotomy permissible per physician discretion. Protocol radiation therapy should be initiated ≥2 weeks after craniotomy.
* Prior partial brain radiation therapy permissible if target volume \< 50% brain and per physician discretion
* Expectant \> 6 months survival
* Ability to understand and the willingness to sign a written informed consent document.
* Fluency in English, able to complete questionnaires and neurocognitive testing
* Ability to undergo MRI with gadolinium examination
* Ability to return for follow-up examinations throughout the course of this study for a maximum of 2 years after radiation treatment completion
* Any prior, concomitant, or post-radiotherapy systemic therapy is permitted at discretion of treating physicians
* Negative pregnancy test for premenopausal women

* Leptomeningeal disease (by any one or more of clinical assessment, radiographic assessment, or cerebrospinal fluid study)
* Prior whole brain radiation therapy
* Pre-existing or current use of memantine or other NMDA antagonists
* Known allergy to contrast used in imaging studies and/or inability to have MRI imaging
* Uncontrolled intercurrent illness that could significantly affect baseline cognitive function as determined by the enrolling clinician, such as symptomatic congestive heart failure, unstable angina pectoris, prior CVA, significant uncontrolled epilepsy or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or unwilling to use appropriate contraception to prevent pregnancy during the time of radiation therapy
* Concurrent participation in an investigational systemic therapy protocol.

Contacts and Locations

Study Contact

Helen A Shih, MD, MS, MPH

CONTACT

(617) 724-9627

hshih@mgh.harvard.edu

Principal Investigator

Helen A Shih, MD, MS, MPH

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Helen A Shih, MD, MS, MPH, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

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 Date2022-02-08

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2022-02-08

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

Brain Metastases

Additional Relevant MeSH Terms

Brain Metastases