RECRUITING

Pre-Operative or Post-Operative Stereotactic Radiosurgery in Treating Patients With Operative Metastatic Brain Tumors

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Conditions

Malignant Solid NeoplasmMetastatic Malignant Neoplasm in the Brain

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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 III trial studies the side effects and how well stereotactic radiosurgery (SRS) works before or after surgery in patients with tumors that has spread to the brain or that can be removed by surgery. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.

Official Title

Pre-Operative vs. Post-Operative Stereotactic Radiosurgery for Operative Metastatic Brain Tumors

Quick Facts

Study Start:2018-11-19
Study Completion:2025-11-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03750227

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 CriteriaExclusion Criteria
  1. * Age \>= 18 years
  2. * Histological or cytological confirmation of solid tumor malignancy and/or clinical history of known or suspected metastatic disease with an intraparenchymal brain tumor consistent with brain metastasis based on clinical and radiologic findings
  3. * Clinical indication for surgical resection of one brain metastasis based on neurosurgery recommendation and patient deemed a surgical candidate
  4. * Clinical indication and plan for stereotactic radiosurgery to all known brain lesions requiring treatment (=\< 10 metastases)
  5. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2
  6. * Provide written informed consent or have a legally authorized representative who is responsible for the care and well-being of the potential study participant, provide consent
  7. * Willing to continue follow-up visits, either at the enrolling institution or with a local medical doctor as clinically appropriate, and according to the study timeline. Clinical notes and digital copies of imaging must be provided to the enrolling site if follow-up is done externally
  1. * Any of the following:
  2. * Pregnant women
  3. * Nursing women
  4. * Men or women of childbearing potential who are unwilling to employ adequate contraception
  5. * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  6. * Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy. \* NOTE: Patients known to be HIV, but without clinical evidence of an immunocompromised state, are eligible for this trial
  7. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  8. * Prior open neurosurgery for malignancy
  9. * Known or clinically suspected primary germ cell tumor, small cell carcinoma, or lymphoma
  10. * History of whole brain radiation therapy (WBRT)
  11. * Known allergy to gadolinium, pacemaker, or other contraindication such as metal implant that is not safe for MRI. Patients with MRI-compatible implants including MRI compatible pacemakers are eligible
  12. * Leptomeningeal metastasis/disease
  13. * A brain metastasis that is located =\< 5 mm of the optic chiasm
  14. * Any brain metastasis \> 5 cm in size
  15. * \> 10 brain metastases
  16. * Indication for surgical resection of \>= 2 brain metastases
  17. * Indication for long-term (anticipated greater than 4 weeks) 4 mg dexamethasone equivalent of steroids or bevacizumab
  18. * Actively enrolled on another brain metastases trial that is assessing the efficacy of either radiation or surgical interventions

Contacts and Locations

Principal Investigator

Elizabeth Yan, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States
National Institutes of Neurological Disorders and Stroke, NIH
Bethesda, Maryland, 20892
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Elizabeth Yan, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

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 Date2018-11-19
Study Completion Date2025-11-08

Study Record Updates

Study Start Date2018-11-19
Study Completion Date2025-11-08

Terms related to this study

Additional Relevant MeSH Terms

  • Malignant Solid Neoplasm
  • Metastatic Malignant Neoplasm in the Brain